Waitlist ControlNCT07002424
Feasibility and Outcomes of Therapist-led Online Cancer Bereavement Groups
A study testing Therapeutic - Psychological in people with Waitlist Control and Intervention (Training) Condition, run by University College, London at 1 site in United Kingdom.
Trial summary
Background: The loss of loved one to cancer brings unique difficulties that impact on the bereavement experience. Mixed support exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waitlist Control, Intervention (Training) Condition
- What is being tested?
- Therapeutic - Psychological
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Adults (aged 18 or over) who are bereaved by cancer, for example losing a partner, family member or friend
- (2) The time since death must have been more than 6 months, so as not to interfere with a natural recovery process (Henk Schut \& Stroebe, 2010)
- (3) Self-referral to The Loss Foundation or via a related organisation
- (4) Have the means to access the therapeutic group online
- (5) Participants consent to attending the intervention with the risk of a delay (e.g. by being randomised to the waitlist or non-waitlist group).
Who cannot join
- Adults at high risk to themselves or others in regard to suicide and/or self-harm
- Significant substance or alcohol misuse which would interfere with participants' ability to take part in the research
- Cannot be involved in other therapy at the same time elsewhere.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Protocol for a Pilot and Feasibility Randomised Controlled Trial of an Online Cancer Bereavement Group.
Background: The loss of loved one to cancer brings unique difficulties that impact on the bereavement experience. Mixed support exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness of online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little empirical evidence for therapist led groups, or for those bereaved by cancer. Objectives: This paper describes the protocol for a pilot feasibility trial evaluating the feasibility, potential effectiveness and acceptability of delivering online therapy groups for those bereaved by cancer. Methods and analysis: It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a future definitive RCT. Participants: A total of 100 adults who have lost a loved one to cancer will be randomised to receive the intervention immediately or after a delay three months later. Interventions: An eight-session online therapeutic group intervention led over 12 weeks based on models of cognitive behavioural therapy, compassion focused therapy and coping with bereavement. Primary outcome measures: Cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Acceptability of the intervention will also be measured including what participants found most helpful or unhelpful about the groups and any adverse outcomes. Data collection will occur at baseline, intervention completion and at follow up, 3 months after intervention completion. Results: The feasibility of trial procedures and the effect of the intervention on the outcomes will be tested,. Conclusions: At intervention completion, it is hoped that participants will show reductions across all outcomes measures with improvements remaining at follow up, compared to the waitlist-control group, warranting the need for a full-scale RCT to establish efficacy. Trial registration (intended registry): Protocol version: 1 (No amendments currently), Issued:
Read the detailed description
The loss of a loved one to cancer brings unique difficulties that impact the bereavement experience. Mixed evidence exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to access including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible, destigmatising and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness for online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little (if any) empirical evidence for therapist led groups, or for those bereaved by cancer.
A group bereavement therapy programme was developed by the Loss Foundation, a national cancer bereavement charity, who initiated the project. It will explore the impact of an eight-session therapeutic group intervention led over 12 weeks on cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Previous research within the Loss Foundation has demonstrated the effectiveness of an in-person cancer bereavement therapeutic group using a transdiagnostic model (Jerome et al., 2018). In this study, it was found that grief intensity and symptoms of posttraumatic stress disorder (PTSD), depression, and anxiety were reduced postintervention, and self-compassion increased. At follow-up, improvement remained for grief, PTSD, and depression. This intervention has been adapted and carried out several times from previous research, including methodological changes such as randomisation to a waitlist control and collection of weekly data. For example, previous research within The Loss Foundation explored the effectiveness of the in-person cancer bereavement therapeutic group compared to waitlist control with findings showing a reduction in grief intensity and increased self-compassion.
As this is the first online therapeutic bereavement group for those bereaved by cancer, this study offers a unique contribution to the literature, addressing a critical gap in the literature on evidence-based therapist led internet interventions for cancer bereaved adults. The intention is to ascertain the feasibility, acceptability and changes in self-report measures of the online version of the adapted group bereavement therapy programme for cancer. This feasibility pilot study will evaluate a randomised controlled trial (RCT) design to explore its suitability for a further full-scale RCT. Outcomes will be assessed by comparing intervention and wait-list control groups at baseline, post each session and postintervention 3 months later in terms of the following primary outcomes: grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection.
Aims and objectives
- The primary aim is to evaluate the feasibility and acceptability of delivering online bereavement group for cancer loss. This refers to feasibility to recruit, retain, randomise and acceptability as tracking participant satisfaction and any adverse outcomes.
- The secondary aim is to explore the preliminary effectiveness by examining whether the online bereavement group intervention leads to improvements on various outcomes, compared to the waitlist control.
The investigators' hypotheses are informed by the results of previous research within The Loss Foundation, and previous literature suggesting that online groups may be similarly effective. In regard to the secondary aim of exploring preliminary effectiveness of the study, the investigators hypothesised that grief intensity and PTSD symptoms, depression, and anxiety will be reduced postintervention, and self-compassion will be increased, showing improvement from baseline, compared to the waitlist control. Further, the investigators hypothesise that at follow-up, improvement will be maintained for grief intensity, PTSD symptoms and depression.
- Being tested
- Therapeutic - Psychological
- Keywords
- Online Bereavement Group, Cancer Loss, Therapist-Led
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic - PsychologicalBehavioural
The intervention uses a transdiagnostic model that incorporates aspects of peer support, psychoeducation, trauma-informed cognitive behavioural therapy (CBT), Compassion focused therapy (CFT) models of distress. It also aligns itself to the Dual Processing Model of coping with bereavement (Stroebe \& Schut, 2010) and Tonkin's model of grief (Tonkin, 1996).
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Participants randomised to non-waitlist, accessing the online bereavement group intervention immediately Receives: Behavioral: Therapeutic - Psychological |
| Waitlist-Control Group | Other | participants randomised to waitlist-control accessing the online bereavement group intervention after a delay (three months later) immediate group Receives: Behavioral: Therapeutic - Psychological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
is a 9-item self-report questionnaire that measures the severity of depressive symptoms. Kroenke et al. (2001) reported that the measure has strong psychometric properties: the internal consistency was 0.89 and test-retest reliability between patient self-report and mental health professional administering the measure telephonically 48 hours later was 0.84. The measure also has good convergent validity (r=0.73) with the mental health subscale of the Short- Form General Health Surv. The PHQ-9 has not been validated with bereaved populations.
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
is a 7-item self-report questionnaire that measures the severity of anxiety symptoms. Spitzer et al., (2006) reported that the measure has strong psychometric properties: the internal consistency was 0.92 and test-retest reliability was 0.83 over a period of a week. The measure has strong convergent validity with the Beck Anxiety Inventory (r=0.72) and the anxiety sub-scale of the Symptom Checklist-90 (r=0.74). The GAD-7 has not been validated with bereaved populations.
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Prolonged Grief Disorder (PG - 13) (Prigerson et al., 2008)
13-item self-report measure that examines three facets of prolonged grief disorder: feelings, thoughts and actions, occurring over the past month. The measure has strong psychometric properties. For example, Ashouri et al., (2024) found that this measure demonstrated good internal consistency (omega coefficient of 0.93), and test-retest reliability with an interval of 6 weeks being 0.89. The PG-13 was shown to be a reliable scale for the assessment of individuals at risk for developing PGD with high scores on internal consistency in bereaved Swedish parents (Pohlkamp et al., 2018). However, these properties have been validated with a few studies.
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
PTSD Checklist for DSM-5
is a 20-item self-report questionnaire that assesses symptoms of PTSD. Blevins et al., (2015) reported that the measure has strong psychometric properties: when tested with trauma-exposed undergraduate students, the internal consistency was 0.94 and the test-retest reliability was 0.82 over a period of a week. There appears to be no validation of the PCL-5 targeting traumatically bereaved individuals.
Measured: Baseline (1 week pre-group) Session 4(week 4) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
The Helpful Aspects of Therapy (HAT; Llewelyn, 1988)
is a post-session self - report questionnaire that asks about perceptions of key change processes in therapy. It is partly qualitative and captures perceptions of helpful and unhelpful aspects of the previous session. It is beyond the scope of this present study to analyse the qualitative data, however this measure provides valuable feedback, which the facilitators can be aware of and address if appropriate.
Researchers will aim to foster trusting relationships to help the participants to feel engaged in the research process. Participants will be given opportunities to share their thoughts and reflections during the group to facilitate engagement with the content.
Measured: Session 1 (Week 1) Session 2 (week 2) Session 3 (week 3) Session 4 (week 4) Session 5 (week 6) Session 6 (week 8) Session 7 (week 10) Session 8 (week 12)
The Self-Compassion Scale (SCS; Neff, 2003)
is a 26-item self-report questionnaire that measures self-compassion. Raes et al. (2011) reported that the measure has strong psychometric properties: the internal consistency was 0.85 and the test-retest reliability over a period of five months was 0.71. The total score of the SCS-SF correlates highly (r=0.98) with the longer 26-item Self-Compassion Scale. Construct validity of the SCS-SF has not been tested but the long version of the SCS was negatively correlated (r=-0.65) with the self-criticism subscale of the Depressive Experiences Questionnaire. The SCS-SF has not been validated with bereaved populations.
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Oxford Grief-Social Disconnection Scale (OG-SD; Smith et al., 2020)
is a 15-item scale developed from interviews with bereaved individuals. Smith et al., (2020) indicate that internal consistency for the total OG-SD and its subscales were good or excellent (Cronbach alpha 0.80). The OG-SD showed a good 7-day-retest reliability across the total and subscales, indicating a temporally stable assessment of perceived social disconnection (test-retest 0.94). However, although overall the OG-SD was deemed stable over time, other two subscales may be less stable over time. The test-retest sample was also relatively small, which means that it is possible that large effects may have been caused within a few individuals.
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Secondary outcomes (29)
Demographic Information- Name
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Demographic Information- Address
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information - Age
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information- Gender
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information- Ethnicity
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. The data securely stored and we have ethical approval to capture special category data for example ethnicity.
Measured: Baseline (1 week pre-group)
Demographic Information- Marital status
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information- Highest level qualification
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information- Employment
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information- Psychological treatment since bereavement
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Demographic Information - Gender of deceased
As part of group therapeutic interventions, The Loss Foundation routinely collects outcome measures and demographic information to evaluate the effectiveness of its services. For therapy groups, the data securely stored.
Measured: Baseline (1 week pre-group)
Bereavement characteristics: Length of relationship with deceased
Bereavement characteristics are also routinely collected by the Loss Foundation:
Measured: Baseline (1 week pre-group)
Bereavement characteristics -Time since death
Measured: Baseline (1 week pre-group)
Bereavement characteristics - Relationship with deceased
Measured: Baseline (1 week pre-group)
Bereavement characteristics - Co-habiting with deceased prior to death
Measured: Baseline (1 week pre-group)
Bereavement characteristics - Contact with deceased prior to death
Measured: Baseline (1 week pre-group)
- Bereavement characteristics Frequency of seeing deceased in 3 months preceding death
Measured: Baseline (1 week pre-group)
Bereavement characteristics Present at the death,
Measured: Baseline (1 week pre-group)
Bereavement characteristics - death of other loved ones in past 3 years.
Measured: Baseline (1 week pre-group)
Recruitment and uptake-Source of referral to the study
Measured: Baseline (1 week pre-group)
Recruitment and uptake- number consenting to participate
Measured: Baseline (1 week pre-group)
Recruitment and uptake- those eligible/willing to be randomised.
Measured: Baseline (1 week pre-group)
Adherence and attrition- A record of participation completion of outcome measurements
Participants will also be prompted by 2-3 reminder emails to complete the outcome measures post each session
Measured: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Adherence and attrition- Attendance
Captured by the zoom meeting report stored on TLF secure server. We let them know as part of the screening process that the programme builds on material session by session and therefore full attendance is required for maximum benefit.
Participants will be asked to complete homework tasks to provide participants with the opportunity to practice and apply the skills and ideas discussed in the sessions as well as develop a sense of self-responsibility. A follow up email will be sent after each session to remind of their home task and self-care.
Measured: Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12)
Acceptability - Intervention
Satisfaction with therapy group (Likert scale)
Measured: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Adverse cirumstances
Feeling supported in distress both during an outside sessions (Likert scale)
Measured: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Intervention Content
Content preference (open ended)
Measured: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Online modality
Experience of online modality of group as opposed to in person (Likert scale)
Measured: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Facilitator effectiveness
Facilitator effectiveness in. Likert scale of: Created a safe and supportive space, Treated group members with respect and empathy, Kept the group on track while allowing flexibility, Managed difficult group dynamics effectively, Delivered clear explanations that helped me to learn about my grief and how to manage it
Measured: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Group size
Acceptability- size of the group (Likert scale) impacting on engagement, connection with others, learning effectiveness, comfort expressing self
Measured: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start15 Jan 2025
- Primary completion5 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Waitlist ControlStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a further full-scale RCT. The study will include two parallel conditions: non-waitlist (online bereavement group), and a wait-list control condition. Four groups are planned: Two whereby participants will be randomised to waitlist (WL) accessing the intervention after a delay and two with participants randomised to non-waitlist (non-WL), accessing the intervention immediately. Both groups will run simultaneously (twice a week, over 8 sessions covering a period of 12 weeks) but the WL groups will run parallel to the non-WL groups, three months later. Assessments will be conducted at baseline and post each session and post-intervention 3 months later.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlie Cole, Clinical Psychologist, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002424
- Sponsor's protocol ID
- Project 0183
- Status last verified
- Oct 2026
- First submitted
- 12 May 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We hope to submit the paper and systematic review for publication in a peer-reviewed journals (e.g. The Journal of Loss and Trauma). Reports will not reveal the identity of anyone who took part. The consent form outlines to participants that their information provided for this study will be published as a report and they will be asked if they would like to receive a copy of it. Data management and monitoring has been registered and approved by the Data Protection Office (reference No Z6364106/2024/11/103 cancer research) in line with UCL's Data Protection Policy. All anonymised data generated or analysed during this study are included in this published article \[and its supplementary information files\].
Publications
Jerome H, Smith KV, Shaw EJ, Szydlowski S, Barker C, Pistrang N, Thompson EH. Effectiveness of a Cancer Bereavement Therapeutic Group. J Loss Trauma. 2019 Jan 7;23(7):574-587. doi: 10.1080/15325024.2018.1518772.
PubMed 30983910King L, Smith KV, Cole CL, Thompson EH. A protocol for a pilot randomised controlled trial of an online cancer bereavement group. Pilot Feasibility Stud. 2026 Feb 26;12(1):46. doi: 10.1186/s40814-026-01785-y.
PubMed 41749396
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for a Pilot and Feasibility Randomised Controlled Trial of an Online Cancer Bereavement Group.
- ClinicalTrials.gov ID
- NCT07002424
- Acronym / sponsor ID
- Project 0183
- Keywords
- Online Bereavement Group, Cancer Loss, Therapist-Led
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The loss of loved one to cancer brings unique difficulties that impact on the bereavement experience. Mixed support exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness of online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little empirical evidence for therapist led groups, or for those bereaved by cancer. Objectives: This paper describes the protocol for a pilot feasibility trial evaluating the feasibility, potential effectiveness and acceptability of delivering online therapy groups for those bereaved by cancer. Methods and analysis: It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a future definitive RCT. Participants: A total of 100 adults who have lost a loved one to cancer will be randomised to receive the intervention immediately or after a delay three months later. Interventions: An eight-session online therapeutic group intervention led over 12 weeks based on models of cognitive behavioural therapy, compassion focused therapy and coping with bereavement. Primary outcome measures: Cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Acceptability of the intervention will also be measured including what participants found most helpful or unhelpful about the groups and any adverse outcomes. Data collection will occur at baseline, intervention completion and at follow up, 3 months after intervention completion. Results: The feasibility of trial procedures and the effect of the intervention on the outcomes will be tested,. Conclusions: At intervention completion, it is hoped that participants will show reductions across all outcomes measures with improvements remaining at follow up, compared to the waitlist-control group, warranting the need for a full-scale RCT to establish efficacy. Trial registration (intended registry): Protocol version: 1 (No amendments currently), Issued:
Detailed description
The loss of a loved one to cancer brings unique difficulties that impact the bereavement experience. Mixed evidence exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to access including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible, destigmatising and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness for online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little (if any) empirical evidence for therapist led groups, or for those bereaved by cancer.
A group bereavement therapy programme was developed by the Loss Foundation, a national cancer bereavement charity, who initiated the project. It will explore the impact of an eight-session therapeutic group intervention led over 12 weeks on cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Previous research within the Loss Foundation has demonstrated the effectiveness of an in-person cancer bereavement therapeutic group using a transdiagnostic model (Jerome et al., 2018). In this study, it was found that grief intensity and symptoms of posttraumatic stress disorder (PTSD), depression, and anxiety were reduced postintervention, and self-compassion increased. At follow-up, improvement remained for grief, PTSD, and depression. This intervention has been adapted and carried out several times from previous research, including methodological changes such as randomisation to a waitlist control and collection of weekly data. For example, previous research within The Loss Foundation explored the effectiveness of the in-person cancer bereavement therapeutic group compared to waitlist control with findings showing a reduction in grief intensity and increased self-compassion.
As this is the first online therapeutic bereavement group for those bereaved by cancer, this study offers a unique contribution to the literature, addressing a critical gap in the literature on evidence-based therapist led internet interventions for cancer bereaved adults. The intention is to ascertain the feasibility, acceptability and changes in self-report measures of the online version of the adapted group bereavement therapy programme for cancer. This feasibility pilot study will evaluate a randomised controlled trial (RCT) design to explore its suitability for a further full-scale RCT. Outcomes will be assessed by comparing intervention and wait-list control groups at baseline, post each session and postintervention 3 months later in terms of the following primary outcomes: grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection.
Aims and objectives
- The primary aim is to evaluate the feasibility and acceptability of delivering online bereavement group for cancer loss. This refers to feasibility to recruit, retain, randomise and acceptability as tracking participant satisfaction and any adverse outcomes.
- The secondary aim is to explore the preliminary effectiveness by examining whether the online bereavement group intervention leads to improvements on various outcomes, compared to the waitlist control.
The investigators' hypotheses are informed by the results of previous research within The Loss Foundation, and previous literature suggesting that online groups may be similarly effective. In regard to the secondary aim of exploring preliminary effectiveness of the study, the investigators hypothesised that grief intensity and PTSD symptoms, depression, and anxiety will be reduced postintervention, and self-compassion will be increased, showing improvement from baseline, compared to the waitlist control. Further, the investigators hypothesise that at follow-up, improvement will be maintained for grief intensity, PTSD symptoms and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a further full-scale RCT. The study will include two parallel conditions: non-waitlist (online bereavement group), and a wait-list control condition. Four groups are planned: Two whereby participants will be randomised to waitlist (WL) accessing the intervention after a delay and two with participants randomised to non-waitlist (non-WL), accessing the intervention immediately. Both groups will run simultaneously (twice a week, over 8 sessions covering a period of 12 weeks) but the WL groups will run parallel to the non-WL groups, three months later. Assessments will be conducted at baseline and post each session and post-intervention 3 months later.
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Therapeutic - PsychologicalParticipants randomised to non-waitlist, accessing the online bereavement group intervention immediately |
| Waitlist-Control Group | Other | Behavioral: Therapeutic - Psychologicalparticipants randomised to waitlist-control accessing the online bereavement group intervention after a delay (three months later) immediate group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (1) Adults (aged 18 or over) who are bereaved by cancer, for example losing a partner, family member or friend
- (2) The time since death must have been more than 6 months, so as not to interfere with a natural recovery process (Henk Schut \& Stroebe, 2010)
- (3) Self-referral to The Loss Foundation or via a related organisation
- (4) Have the means to access the therapeutic group online
- (5) Participants consent to attending the intervention with the risk of a delay (e.g. by being randomised to the waitlist or non-waitlist group).
Key exclusion criteria (3 listed)
- Adults at high risk to themselves or others in regard to suicide and/or self-harm
- Significant substance or alcohol misuse which would interfere with participants' ability to take part in the research
- Cannot be involved in other therapy at the same time elsewhere.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic - PsychologicalThe intervention uses a transdiagnostic model that incorporates aspects of peer support, psychoeducation, trauma-informed cognitive behavioural therapy (CBT), Compassion focused therapy (CFT) models of distress. It also aligns itself to the Dual Processing Model of coping with bereavement (Stroebe \& Schut, 2010) and Tonkin's model of grief (Tonkin, 1996). | Behavioural | Immediate Treatment, Waitlist-Control Group |
Primary outcome
Mood Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 9-item self-report questionnaire that measures the severity of depressive symptoms. Kroenke et al. (2001) reported that the measure has strong psychometric properties: the internal consistency was 0.89 and test-retest reliability between patient self-report and mental health professional administering the measure telephonically 48 hours later was 0.84. The measure also has good convergent validity (r=0.73) with the mental health subscale of the Short- Form General Health Surv. The PHQ-9 has not been validated with bereaved populations.
Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 7-item self-report questionnaire that measures the severity of anxiety symptoms. Spitzer et al., (2006) reported that the measure has strong psychometric properties: the internal consistency was 0.92 and test-retest reliability was 0.83 over a period of a week. The measure has strong convergent validity with the Beck Anxiety Inventory (r=0.72) and the anxiety sub-scale of the Symptom Checklist-90 (r=0.74). The GAD-7 has not been validated with bereaved populations.
Prolonged Grief Disorder (PG - 13) (Prigerson et al., 2008)
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
13-item self-report measure that examines three facets of prolonged grief disorder: feelings, thoughts and actions, occurring over the past month. The measure has strong psychometric properties. For example, Ashouri et al., (2024) found that this measure demonstrated good internal consistency (omega coefficient of 0.93), and test-retest reliability with an interval of 6 weeks being 0.89. The PG-13 was shown to be a reliable scale for the assessment of individuals at risk for developing PGD with high scores on internal consistency in bereaved Swedish parents (Pohlkamp et al., 2018). However, these properties have been validated with a few studies.
PTSD Checklist for DSM-5
Time frame: Baseline (1 week pre-group) Session 4(week 4) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 20-item self-report questionnaire that assesses symptoms of PTSD. Blevins et al., (2015) reported that the measure has strong psychometric properties: when tested with trauma-exposed undergraduate students, the internal consistency was 0.94 and the test-retest reliability was 0.82 over a period of a week. There appears to be no validation of the PCL-5 targeting traumatically bereaved individuals.
The Helpful Aspects of Therapy (HAT; Llewelyn, 1988)
Time frame: Session 1 (Week 1) Session 2 (week 2) Session 3 (week 3) Session 4 (week 4) Session 5 (week 6) Session 6 (week 8) Session 7 (week 10) Session 8 (week 12)
is a post-session self - report questionnaire that asks about perceptions of key change processes in therapy. It is partly qualitative and captures perceptions of helpful and unhelpful aspects of the previous session. It is beyond the scope of this present study to analyse the qualitative data, however this measure provides valuable feedback, which the facilitators can be aware of and address if appropriate. Researchers will aim to foster trusting relationships to help the participants to feel engaged in the research process. Participants will be given opportunities to share their thoughts and reflections during the group to facilitate engagement with the content.
The Self-Compassion Scale (SCS; Neff, 2003)
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 26-item self-report questionnaire that measures self-compassion. Raes et al. (2011) reported that the measure has strong psychometric properties: the internal consistency was 0.85 and the test-retest reliability over a period of five months was 0.71. The total score of the SCS-SF correlates highly (r=0.98) with the longer 26-item Self-Compassion Scale. Construct validity of the SCS-SF has not been tested but the long version of the SCS was negatively correlated (r=-0.65) with the self-criticism subscale of the Depressive Experiences Questionnaire. The SCS-SF has not been validated with bereaved populations.
Oxford Grief-Social Disconnection Scale (OG-SD; Smith et al., 2020)
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
is a 15-item scale developed from interviews with bereaved individuals. Smith et al., (2020) indicate that internal consistency for the total OG-SD and its subscales were good or excellent (Cronbach alpha 0.80). The OG-SD showed a good 7-day-retest reliability across the total and subscales, indicating a temporally stable assessment of perceived social disconnection (test-retest 0.94). However, although overall the OG-SD was deemed stable over time, other two subscales may be less stable over time. The test-retest sample was also relatively small, which means that it is possible that large effects may have been caused within a few individuals.
29 secondary outcomes
Demographic Information- Name
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Demographic Information- Address
Time frame: Baseline (1 week pre-group)
Demographic Information - Age
Time frame: Baseline (1 week pre-group)
Demographic Information- Gender
Time frame: Baseline (1 week pre-group)
Demographic Information- Ethnicity
Time frame: Baseline (1 week pre-group)
Demographic Information- Marital status
Time frame: Baseline (1 week pre-group)
Demographic Information- Highest level qualification
Time frame: Baseline (1 week pre-group)
Demographic Information- Employment
Time frame: Baseline (1 week pre-group)
Demographic Information- Psychological treatment since bereavement
Time frame: Baseline (1 week pre-group)
Demographic Information - Gender of deceased
Time frame: Baseline (1 week pre-group)
Bereavement characteristics: Length of relationship with deceased
Time frame: Baseline (1 week pre-group)
Bereavement characteristics -Time since death
Time frame: Baseline (1 week pre-group)
Bereavement characteristics - Relationship with deceased
Time frame: Baseline (1 week pre-group)
Bereavement characteristics - Co-habiting with deceased prior to death
Time frame: Baseline (1 week pre-group)
Bereavement characteristics - Contact with deceased prior to death
Time frame: Baseline (1 week pre-group)
- Bereavement characteristics Frequency of seeing deceased in 3 months preceding death
Time frame: Baseline (1 week pre-group)
Bereavement characteristics Present at the death,
Time frame: Baseline (1 week pre-group)
Bereavement characteristics - death of other loved ones in past 3 years.
Time frame: Baseline (1 week pre-group)
Recruitment and uptake-Source of referral to the study
Time frame: Baseline (1 week pre-group)
Recruitment and uptake- number consenting to participate
Time frame: Baseline (1 week pre-group)
Recruitment and uptake- those eligible/willing to be randomised.
Time frame: Baseline (1 week pre-group)
Adherence and attrition- A record of participation completion of outcome measurements
Time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)
Adherence and attrition- Attendance
Time frame: Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12)
Acceptability - Intervention
Time frame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Adverse cirumstances
Time frame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Intervention Content
Time frame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Online modality
Time frame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Facilitator effectiveness
Time frame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Acceptability- Group size
Time frame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 30983910Jerome H, Smith KV, Shaw EJ, Szydlowski S, Barker C, Pistrang N, Thompson EH. Effectiveness of a Cancer Bereavement Therapeutic Group. J Loss Trauma. 2019 Jan 7;23(7):574-587. doi: 10.1080/15325024.2018.1518772.
- Derived from this study: PubMed 41749396King L, Smith KV, Cole CL, Thompson EH. A protocol for a pilot randomised controlled trial of an online cancer bereavement group. Pilot Feasibility Stud. 2026 Feb 26;12(1):46. doi: 10.1186/s40814-026-01785-y.
- Individual participant dataSharing planned: No. We hope to submit the paper and systematic review for publication in a peer-reviewed journals (e.g. The Journal of Loss and Trauma). Reports will not reveal the identity of anyone who took part. The consent form outlines to participants that their information provided for this study will be published as a report and they will be asked if they would like to receive a copy of it. Data management and monitoring has been registered and approved by the Data Protection Office (reference No Z6364106/2024/11/103 cancer research) in line with UCL's Data Protection Policy. All anonymised data generated or analysed during this study are included in this published article [and its supplementary information files].
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Cole, Clinical Psychologist principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic - Psychological in people with Waitlist Control and Intervention (Training) Condition, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (time frame: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07002424, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.