Gynecological CancerEPELITNCT03553784
Low-Intensity CBT for Gynaecological Cancer Survivors
A study testing Group delivered Low Intensity Cognitive Behavioural Therapy in people with Gynecological Cancer, run by University of Chester at 1 site in United Kingdom.
Trial summary
There are 21,500 gynaecological cancers diagnosed in the UK each year. These are often diagnosed later than common cancers, which is predictive of low survival and high psychological distress. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Gynecological Cancer
- What is being tested?
- Group delivered Low Intensity Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2018to 2 May 2020
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be over the age of 16.
- Must have received a gynecological cancer diagnosis.
- Must have completed first line treatment within four months of the study start date (not restricted to any specific modality of treatment).
- Must be able to speak English.
- Must be able to provide consent.
Who cannot join
- Any patients that are unlikely to survive for the full five-month duration of the study.
- Any patient who does not have sufficient English language ability to complete data collection.
- Any patients who are notable to provide consent will not be included as this group would be unlikely to be able to complete data collection even if adjustments to the consent procedure were made.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chester Research Unit for the Psychology of Health
Chester, Cheshire, CH1 4BJ
About this study
Official title: Evaluating Process and Effectiveness of Low-intensity Group Cognitive Behavioural Therapy for Women With Gynaecological Cancer: The EPELIT Study
There are 21,500 gynaecological cancers diagnosed in the UK each year. These are often diagnosed later than common cancers, which is predictive of low survival and high psychological distress. There are few studies published which accurately map the profile of distress and supportive care needs in gynaecological cancer patients, nor which test psychological interventions to support this group.
This study will use a non-randomised controlled trial design to explore the potential benefits of taking part in a psychological intervention designed in this group of women. The intervention is group-delivered and runs for eight weeks. It is delivered by psychologists, psychological wellbeing practitioners, and cancer nurse specialists. The investigators will use validated self-report questionnaires to assess how helpful this intervention is at reducing distress and improving quality of life in the participants. This will be done in comparison with a treatment-as-usual control group recruited from a second clinical site. This second group of participants will not receive the psychological intervention, but they will complete the same assessments, at the same time points. To ensure participants are well supported, data collection in control control group participants will be done by telephone interview rather than self-report questionnaires. Both groups of participants will undertake a three-month follow-up assessment to check the longer-term effectiveness of the psychological intervention.
- Conditions
- Gynecological Cancer
- Being tested
- Group delivered Low Intensity Cognitive Behavioural Therapy
- Keywords
- Cancer, Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group delivered Low Intensity Cognitive Behavioural TherapyOther
The intervention is group-delivered, low-intensity CBT similar to that used in IAPT (Improving Access to Psychological Therapies) Services in England. This intervention is already being offered as part of standard care at the Intervention site, and will not be altered by the study protocol, other than the requirement to complete a few more questionnaires. The intervention group meets weekly for eight weeks, and is facilitated by a clinical psychologist, a psychological well-being practitioner and a clinical nurse specialist from the medical oncology team. Content of the intervention is broad CBT, combining aspects of second-wave CBT, with elements of Narrative Therapy and ACT.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Group delivered Low Intensity Cognitive Behavioural Therapy (CBT). Receives: Other: Group delivered Low Intensity Cognitive Behavioural Therapy |
| Control Group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
A nine-item screening tool to assess symptoms of depression in the responding individual (Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to appetite, concentration, energy hopelessness, and suicidality. Higher scores indicate higher levels of distress. The PHQ-9 has been established as a valid and reliable measure of depression severity (Kroenke et al., 2001).
Measured: last 2 weeks
Generalized Anxiety Disorder (GAD-7)
A seven-item screening tool to assess symptoms of anxiety in the responding individual (Spitzer, Kroenke, Williams, \& Löwe, 2006). The GAD-7 uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. The GAD-7 has been established as an accurate measure of anxiety (Swinson, 2006).
Measured: last 2 weeks
Secondary outcomes (1)
The Functional Assessment of Cancer Therapy-General (FACT-G)
A 33-item screening tool to assess quality-of-life in patients receiving cancer treatment (Cella et al., 1993). The FACT-G uses a five-point rating scale (ranging from 0 to 4) asking how often in the last seven days patients have experienced difficulties in four dimensions of well-being: physical; social/family; emotional; functional. Higher scores indicate lower quality-of-life. The FACT-G is a well validated tool for measuring quality-of-life in cancer sample (Luckett et al., 2011).
Measured: last 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start3 Apr 2018
- Primary completion30 Jan 2020
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic non-randomized controlled design.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas J. Hulbert-Williams, University of Chester
- Investigators
- Nicholas J Hulbert-Williams, PhD, Principal investigator, University of Chester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553784
- Sponsor's protocol ID
- 239518
- Acronym
- EPELIT
- Status last verified
- May 2020
- First submitted
- 30 May 2018
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised dataset will be prepared once our study is completed, primarily to ensure that access can be provided to journal editors and peer reviewers if requested through the publishing and dissemination process. We would consider requests to share this data with other research teams, provided that individual participants have consented to this . In releasing such data we will include self-report psychological measures, demographics as reported to the research team by the participant, and clinical data as extracted from patient records. We will not release information on hospital site, simply reporting that participants were recruited from anonymised UK hospitals. Thus, without access to how these match NHS records, it ought not to be possible to identify individuals from this dataset. This is carefully explained to participants in the study information sheets as an assurance of commitment to participant anonymity.
Publications
Hulbert-Williams NJ, Hulbert-Williams L, Flynn RJ, Pendrous R, MacDonald-Smith C, Mullard A, Swash B, Evans G, Price A. Evaluating process and effectiveness of a low-intensity CBT intervention for women with gynaecological cancer (the EPELIT Trial). AMRC Open Res. 2021 Mar 29;3:12. doi: 10.12688/amrcopenres.12971.1. eCollection 2021.
PubMed 38708072
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Process and Effectiveness of Low-intensity Group Cognitive Behavioural Therapy for Women With Gynaecological Cancer: The EPELIT Study
- ClinicalTrials.gov ID
- NCT03553784
- Acronym / sponsor ID
- EPELIT / 239518
- Conditions
- Gynecological Cancer
- Keywords
- Cancer, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChesterUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 12 Jun 2018 (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.
There are 21,500 gynaecological cancers diagnosed in the UK each year. These are often diagnosed later than common cancers, which is predictive of low survival and high psychological distress. There are few studies published which accurately map the profile of distress and supportive care needs in gynaecological cancer patients, nor which test psychological interventions to support this group.
This study will use a non-randomised controlled trial design to explore the potential benefits of taking part in a psychological intervention designed in this group of women. The intervention is group-delivered and runs for eight weeks. It is delivered by psychologists, psychological wellbeing practitioners, and cancer nurse specialists. The investigators will use validated self-report questionnaires to assess how helpful this intervention is at reducing distress and improving quality of life in the participants. This will be done in comparison with a treatment-as-usual control group recruited from a second clinical site. This second group of participants will not receive the psychological intervention, but they will complete the same assessments, at the same time points. To ensure participants are well supported, data collection in control control group participants will be done by telephone interview rather than self-report questionnaires. Both groups of participants will undertake a three-month follow-up assessment to check the longer-term effectiveness of the psychological intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic non-randomized controlled design.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Group delivered Low Intensity Cognitive Behavioural TherapyGroup delivered Low Intensity Cognitive Behavioural Therapy (CBT). |
| Control Group | No intervention | –No intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must be over the age of 16.
- Must have received a gynecological cancer diagnosis.
- Must have completed first line treatment within four months of the study start date (not restricted to any specific modality of treatment).
- Must be able to speak English.
- Must be able to provide consent.
Key exclusion criteria (3 listed)
- Any patients that are unlikely to survive for the full five-month duration of the study.
- Any patient who does not have sufficient English language ability to complete data collection.
- Any patients who are notable to provide consent will not be included as this group would be unlikely to be able to complete data collection even if adjustments to the consent procedure were made.
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 |
|---|---|---|
| Group delivered Low Intensity Cognitive Behavioural TherapyThe intervention is group-delivered, low-intensity CBT similar to that used in IAPT (Improving Access to Psychological Therapies) Services in England. This intervention is already being offered as part of standard care at the Intervention site, and will not be altered by the study protocol, other than the requirement to complete a few more questionnaires. The intervention group meets weekly for eight weeks, and is facilitated by a clinical psychologist, a psychological well-being practitioner and a clinical nurse specialist from the medical oncology team. Content of the intervention is broad CBT, combining aspects of second-wave CBT, with elements of Narrative Therapy and ACT. | Other | Intervention Group |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: last 2 weeks
A nine-item screening tool to assess symptoms of depression in the responding individual (Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to appetite, concentration, energy hopelessness, and suicidality. Higher scores indicate higher levels of distress. The PHQ-9 has been established as a valid and reliable measure of depression severity (Kroenke et al., 2001).
Generalized Anxiety Disorder (GAD-7)
Time frame: last 2 weeks
A seven-item screening tool to assess symptoms of anxiety in the responding individual (Spitzer, Kroenke, Williams, \& Löwe, 2006). The GAD-7 uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. The GAD-7 has been established as an accurate measure of anxiety (Swinson, 2006).
1 secondary outcome
The Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: last 7 days
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 11 May 2020.
- Derived from this study: PubMed 38708072Hulbert-Williams NJ, Hulbert-Williams L, Flynn RJ, Pendrous R, MacDonald-Smith C, Mullard A, Swash B, Evans G, Price A. Evaluating process and effectiveness of a low-intensity CBT intervention for women with gynaecological cancer (the EPELIT Trial). AMRC Open Res. 2021 Mar 29;3:12. doi: 10.12688/amrcopenres.12971.1. eCollection 2021.
- Individual participant dataSharing planned: Yes. An anonymised dataset will be prepared once our study is completed, primarily to ensure that access can be provided to journal editors and peer reviewers if requested through the publishing and dissemination process. We would consider requests to share this data with other research teams, provided that individual participants have consented to this . In releasing such data we will include self-report psychological measures, demographics as reported to the research team by the participant, and clinical data as extracted from patient records. We will not release information on hospital site, simply reporting that participants were recruited from anonymised UK hospitals. Thus, without access to how these match NHS records, it ought not to be possible to identify individuals from this dataset. This is carefully explained to participants in the study information sheets as an assurance of commitment to participant anonymity.
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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.
Nicholas J Hulbert-Williams, PhD principal investigator
University of Chester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group delivered Low Intensity Cognitive Behavioural Therapy in people with Gynecological Cancer, run by University of Chester 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 11 May 2020. 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?
Patient Health Questionnaire (PHQ-9) (time frame: last 2 weeks). The study lists 2 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 NCT03553784, which also lists 1 linked publication.
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 11 May 2020.