CancerNCT03341364
Acceptance and Commitment Based Group Therapy for Cancer Patients
A study testing ACT-based group therapy and ACT individual treatment in people with Cancer and Psychological Distress, run by Region Skane at 1 site in Sweden.
Trial summary
This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Half of the participants will receive ACT in a group setting, while the other half will receive individual ACT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychological Distress
- What is being tested?
- ACT-based group therapy and ACT individual treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2020to 31 Dec 2022
- 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
- Age ≥ 18 years
- Able to speak and understand the Swedish language
- Cancer patients at hospitals in Skånevård Sund (geographical area)
- Experience of psychological distress related to cancer diagnosis or cancer treatment
- Stable and planned cancer treatment or no ongoing treatment
Who cannot join
- Severe cognitive problems
- Severe psychiatric disorder
- Ongoing substance abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Cancerrehabiliteringsmottagningen Helsingborg
Helsingborg, Skåne County, 25187
About this study
Official title: Acceptance and Commitment Based Group Therapy for Cancer Patients: a Pilot Study Comparing ACT-group Therapy With Individual ACT Therapy for Cancer Patients Experiencing Psychological Distress
This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Half of the participants will receive ACT in a group setting, while the other half will receive individual ACT.
Read the detailed description
This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Participants will be recruited from referrals to the Cancer Rehabilitation Unit at Helsingborg Hospital, Sweden. A total number of 12-20 participants will be assigned to either the experimental group, receiving ACT group therapy, or the Active Control group, receiving individual ACT therapy. Both therapy interventions aim at increasing psychological flexibility. Sociodemographic as well as Medical information regarding their somatic disease will be collected at baseline assessment.
- Conditions
- Cancer, Psychological Distress
- Being tested
- ACT-based group therapy, ACT individual treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based group therapyBehavioural
6 group therapy sessions over 6 weeks (one session à 2 hours weekly), plus one follow-up session 6 weeks after last session. The sessions are lead by a psychologist and a social worker. Each session containing discussions, experimental exercises and home-work assignment.
ACT individual treatmentBehavioural
3-12 individual therapy sessions over 3-16 weeks, plus one follow-up session 6 weeks after last session, lead by a clinical psychologist. Each session containing discussion, experimental exercises and home-work assignment.
| Study group | Role | What they receive |
|---|---|---|
| ACT group treatment | Experimental | Participants receiving the ACT-based group therapy. Receives: Behavioral: ACT-based group therapy |
| ACT individual | Active comparator | Participants receiving individual ACT-based therapy. Receives: Behavioral: ACT individual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility.
Measured: Baseline and end of treatment (baseline+3-16 weeks)
Secondary outcomes (11)
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility.
Measured: Baseline and follow up (6 weeks after end of treatment)
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility.
Measured: End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment)
Change in Generalized Anxiety Disorder 7 (GAD-7)
Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety.
Measured: Baseline and end of treatment (baseline+3-16 weeks)
Change in Generalized Anxiety Disorder 7 (GAD-7)
Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety.
Measured: Baseline and follow up (6 weeks after end of treatment)
Change in Generalized Anxiety Disorder 7 (GAD-7)
Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety.
Measured: End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)
Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression.
Measured: End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)
Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression.
Measured: Baseline and follow-up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)
Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression.
Measured: Baseline and end of treatment (baseline + 3-16 weeks)
Change in RAND 36-item Health Survey (RAND-36)
Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best.
Measured: Baseline and end of treatment (baseline + 3-16 weeks)
Change in RAND 36-item Health Survey (RAND-36)
Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best.
Measured: Baseline and follow up (6 weeks after end of treatment)
Change in RAND 36-item Health Survey (RAND-36)
Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best.
Measured: End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start10 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022 (estimated)
Why it stopped: Central contact person ended employment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Recruitment of participants to the group intervention will start first. When a maximum of 10 participants have been recruited to the group intervention and/or one week before start of group intervention, recruitment to the Active Control group will start. The individual therapies will start at different times, depending on the flow of referrals.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatrice Nystrom, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341364
- Sponsor's protocol ID
- 2017/602
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2017
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Based Group Therapy for Cancer Patients: a Pilot Study Comparing ACT-group Therapy With Individual ACT Therapy for Cancer Patients Experiencing Psychological Distress
- ClinicalTrials.gov ID
- NCT03341364
- Acronym / sponsor ID
- 2017/602
- Conditions
- Cancer, Psychological Distress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Central contact person ended employment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Nov 2017 (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.
This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Half of the participants will receive ACT in a group setting, while the other half will receive individual ACT.
Detailed description
This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Participants will be recruited from referrals to the Cancer Rehabilitation Unit at Helsingborg Hospital, Sweden. A total number of 12-20 participants will be assigned to either the experimental group, receiving ACT group therapy, or the Active Control group, receiving individual ACT therapy. Both therapy interventions aim at increasing psychological flexibility. Sociodemographic as well as Medical information regarding their somatic disease will be collected at baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Recruitment of participants to the group intervention will start first. When a maximum of 10 participants have been recruited to the group intervention and/or one week before start of group intervention, recruitment to the Active Control group will start. The individual therapies will start at different times, depending on the flow of referrals.
| Arm | Type | Receives |
|---|---|---|
| ACT group treatment | Experimental | Behavioral: ACT-based group therapyParticipants receiving the ACT-based group therapy. |
| ACT individual | Active comparator | Behavioral: ACT individual treatmentParticipants receiving individual ACT-based therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Able to speak and understand the Swedish language
- Cancer patients at hospitals in Skånevård Sund (geographical area)
- Experience of psychological distress related to cancer diagnosis or cancer treatment
- Stable and planned cancer treatment or no ongoing treatment
Key exclusion criteria (3 listed)
- Severe cognitive problems
- Severe psychiatric disorder
- Ongoing substance abuse
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 |
|---|---|---|
| ACT-based group therapy6 group therapy sessions over 6 weeks (one session à 2 hours weekly), plus one follow-up session 6 weeks after last session. The sessions are lead by a psychologist and a social worker. Each session containing discussions, experimental exercises and home-work assignment. | Behavioural | ACT group treatment |
| ACT individual treatment3-12 individual therapy sessions over 3-16 weeks, plus one follow-up session 6 weeks after last session, lead by a clinical psychologist. Each session containing discussion, experimental exercises and home-work assignment. | Behavioural | ACT individual |
Primary outcome
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Time frame: Baseline and end of treatment (baseline+3-16 weeks)
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility.
11 secondary outcomes
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Time frame: Baseline and follow up (6 weeks after end of treatment)
Change in Swedish Acceptance and Action Questionnaire (SAAQ)
Time frame: End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment)
Change in Generalized Anxiety Disorder 7 (GAD-7)
Time frame: Baseline and end of treatment (baseline+3-16 weeks)
Change in Generalized Anxiety Disorder 7 (GAD-7)
Time frame: Baseline and follow up (6 weeks after end of treatment)
Change in Generalized Anxiety Disorder 7 (GAD-7)
Time frame: End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)
Time frame: End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline and follow-up (6 weeks after end of treatment)
Change in Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline and end of treatment (baseline + 3-16 weeks)
Change in RAND 36-item Health Survey (RAND-36)
Time frame: Baseline and end of treatment (baseline + 3-16 weeks)
Change in RAND 36-item Health Survey (RAND-36)
Time frame: Baseline and follow up (6 weeks after end of treatment)
Change in RAND 36-item Health Survey (RAND-36)
Time frame: End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Beatrice Nystrom, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-based group therapy and ACT individual treatment in people with Cancer and Psychological Distress, run by Region Skane at 1 site in Sweden.
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: withdrawn, as of the sponsor's last update on 24 Oct 2023. 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 Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Swedish Acceptance and Action Questionnaire (SAAQ) (time frame: Baseline and end of treatment (baseline+3-16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2023.