Esophageal CancerNCT02491372
A Pilot Study of the Effectiveness of Acceptance and Commitment Therapy With a Post-Upper GI Cancer Population
A study testing Acceptance and Commitment Therapy in people with Esophageal Cancer, run by Martin Dempster.
Trial summary
This pilot research study aims to assess the effectiveness of an Acceptance and Commitment Therapy (ACT; Hayes Strosahl \& Wilson, 2011) group based intervention at improving quality of life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer following curative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Apr 2016
- 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
- Adults diagnosed with Upper GI/ Oesophageal cancer that have undergone an oesphagectomy between three to 12 months previously
Who cannot join
- Are in receipt of a psychological intervention specifically to deal with the side effects of their oesphagectomy prior to stating the study group.
- Have had a reoccurrence of the disease since their operation
- Show evidence of cognitive impairment which may impede their ability to engage with the intervention.
- Are zero to 3 months post medical intervention to cure their Upper GI/oesophageal cancer (oesphagetomy procedure).
About this study
This pilot research study aims to assess the effectiveness of an Acceptance and Commitment Therapy (ACT; Hayes Strosahl \& Wilson, 2011) group based intervention at improving quality of life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer following curative treatment. Participants will be invited to take part in an eight week intervention with outcomes being measured at baseline, midpoint, post-intervention and two month follow up. Outcomes will be compared with a randomised control group who will receive treatment as usual. Research has indicated that this population are under considerable psychological distress however within the UK there are currently no specifically tailored psychological interventions on offer to reduce this distress (Dempster, McCorry, Brennan, Donnelly, Murray \& Johnston, 2012).
Read the detailed description
Design: This pilot study will take the form of a 2 group randomised controlled trial (intervention vs treatment as usual). Measures will be administered at baseline, midpoint, post-intervention and 2 month follow-up.
Setting: Outpatients' clinic. Target population: Adults with oesphagectomy in the previous 3-12 months for oesophageal cancer.
Exclusion Criteria: In receipt of a psychological intervention; have had a reoccurrence of the disease since their surgery; evidence of cognitive impairment impeding ability to engage with the intervention.
Health technology: A group-based acceptance and commitment therapy (ACT) intervention. There will be 2 intervention groups, both of which will receive an 8 week (1.5 hours per week) intervention.
Measurement of costs and outcomes: Participants will be allocated to treatment or control using a randomisation procedure, generated by a statistician outside the research team.
According to the COMET initiative, there are no recommended core outcomes available for use in oesophageal cancer. Work to develop these outcome measures is currently underway and the investigators will contact the authors of this work for the latest updates prior to submitting a full application to ensure that our choice of outcome measures is commensurate with any recommendations they are about to make. In the absence of this work being advanced sufficiently to inform this proposal, the following reliable and valid measures will be used: EORTC Quality of Life Questionnaire and Oesophageal Cancer Module, Acceptance and Action Questionnaire II, which provides a measure of psychological inflexibility, and (secondarily) Depression, Anxiety and Stress Scale.
Sample size: A sample size of 50 (25 per study arm).[42] This will also allow us to estimate a participation rate of 70% to within a 95% confidence interval of ±13%, which will inform the design of the definitive trial.
Current pathway: Patients can seek support for emotional issues from the specialist nurses in the service.
Expertise: Multidisciplinary team including cancer specialist nurses, a service user representative, health economist, statistician, psychologists and with expertise in the intervention to be tested, trials methodology, qualitative and quantitative methods, and research among people with oesophageal cancer
- Conditions
- Esophageal Cancer
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
ACT is a psychological intervention that aims to promote adaptive coping and encourages participants to move their focus away from trying to control emotions to accepting and adapting to them. It is relevant to all patients, not just those who are currently distressed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Acceptance and commitment therapy group Receives: Behavioral: Acceptance and Commitment Therapy |
| Comparison | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological flexibility assessed using the Acceptance and Action Questionnaire II
Measured: Pretest, approximately 8 weeks later and then another 3 months later
Secondary outcomes (2)
Change in Depression, anxiety and stress using the Depression Anxiety and Stress Scale 21
Measured: Pretest, approximately 8 weeks later and then another 3 months later
Change in Quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Oesophageal and Gastric Cancer
Measured: Pretest, approximately 8 weeks later and then another 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Unable to recruit sufficient number of participants in the time available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Dempster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Sponsor-investigator, Martin Dempster, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491372
- Sponsor's protocol ID
- B15/01
- Status last verified
- Apr 2016
- First submitted
- 5 Jun 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of Acceptance and Commitment Therapy With a Post-Upper GI Cancer Population
- ClinicalTrials.gov ID
- NCT02491372
- Acronym / sponsor ID
- B15/01
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit sufficient number of participants in the time available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Martin DempsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- 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 pilot research study aims to assess the effectiveness of an Acceptance and Commitment Therapy (ACT; Hayes Strosahl \& Wilson, 2011) group based intervention at improving quality of life (QOL) and increasing Psychological Flexibility with survivors of Upper GI cancer following curative treatment. Participants will be invited to take part in an eight week intervention with outcomes being measured at baseline, midpoint, post-intervention and two month follow up. Outcomes will be compared with a randomised control group who will receive treatment as usual. Research has indicated that this population are under considerable psychological distress however within the UK there are currently no specifically tailored psychological interventions on offer to reduce this distress (Dempster, McCorry, Brennan, Donnelly, Murray \& Johnston, 2012).
Detailed description
Design: This pilot study will take the form of a 2 group randomised controlled trial (intervention vs treatment as usual). Measures will be administered at baseline, midpoint, post-intervention and 2 month follow-up.
Setting: Outpatients' clinic. Target population: Adults with oesphagectomy in the previous 3-12 months for oesophageal cancer.
Exclusion Criteria: In receipt of a psychological intervention; have had a reoccurrence of the disease since their surgery; evidence of cognitive impairment impeding ability to engage with the intervention.
Health technology: A group-based acceptance and commitment therapy (ACT) intervention. There will be 2 intervention groups, both of which will receive an 8 week (1.5 hours per week) intervention.
Measurement of costs and outcomes: Participants will be allocated to treatment or control using a randomisation procedure, generated by a statistician outside the research team.
According to the COMET initiative, there are no recommended core outcomes available for use in oesophageal cancer. Work to develop these outcome measures is currently underway and the investigators will contact the authors of this work for the latest updates prior to submitting a full application to ensure that our choice of outcome measures is commensurate with any recommendations they are about to make. In the absence of this work being advanced sufficiently to inform this proposal, the following reliable and valid measures will be used: EORTC Quality of Life Questionnaire and Oesophageal Cancer Module, Acceptance and Action Questionnaire II, which provides a measure of psychological inflexibility, and (secondarily) Depression, Anxiety and Stress Scale.
Sample size: A sample size of 50 (25 per study arm).[42] This will also allow us to estimate a participation rate of 70% to within a 95% confidence interval of ±13%, which will inform the design of the definitive trial.
Current pathway: Patients can seek support for emotional issues from the specialist nurses in the service.
Expertise: Multidisciplinary team including cancer specialist nurses, a service user representative, health economist, statistician, psychologists and with expertise in the intervention to be tested, trials methodology, qualitative and quantitative methods, and research among people with oesophageal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and commitment therapy group |
| Comparison | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults diagnosed with Upper GI/ Oesophageal cancer that have undergone an oesphagectomy between three to 12 months previously
Key exclusion criteria (4 listed)
- Are in receipt of a psychological intervention specifically to deal with the side effects of their oesphagectomy prior to stating the study group.
- Have had a reoccurrence of the disease since their operation
- Show evidence of cognitive impairment which may impede their ability to engage with the intervention.
- Are zero to 3 months post medical intervention to cure their Upper GI/oesophageal cancer (oesphagetomy procedure).
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 |
|---|---|---|
| Acceptance and Commitment TherapyACT is a psychological intervention that aims to promote adaptive coping and encourages participants to move their focus away from trying to control emotions to accepting and adapting to them. It is relevant to all patients, not just those who are currently distressed. | Behavioural | Intervention |
Primary outcome
Change in psychological flexibility assessed using the Acceptance and Action Questionnaire II
Time frame: Pretest, approximately 8 weeks later and then another 3 months later
2 secondary outcomes
Change in Depression, anxiety and stress using the Depression Anxiety and Stress Scale 21
Time frame: Pretest, approximately 8 weeks later and then another 3 months later
Change in Quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Oesophageal and Gastric Cancer
Time frame: Pretest, approximately 8 weeks later and then another 3 months later
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 5 Apr 2016.
Related trials for Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingPhase 2
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers
Subjects With Resectable and Localized Gastric Cancer, Subjects With Resectable Esophageal Cancer or Liver Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Esophageal Cancer, run by Martin Dempster.
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 1 inclusion and 4 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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 psychological flexibility assessed using the Acceptance and Action Questionnaire II (time frame: Pretest, approximately 8 weeks later and then another 3 months later). 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 5 Apr 2016; AzTrials last refreshed its copy on 2 Nov 2026.