Malignant Female Reproductive System NeoplasmNCT03112668
Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners
A study testing Cognitive Behavior Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm and Malignant Hepatobiliary Neoplasm, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Malignant Hepatobiliary Neoplasm, Partner
- What is being tested?
- Cognitive Behavior Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2017to 25 Jan 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
- Married or cohabiting with a significant other of either gender for more than one year
- At the time of recruitment, a life expectancy of greater than 6 months and/or a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- English speaking
- No significant hearing impairment that would prevent participation in sessions
- Live within a 1 hour commuting distance from Rutgers Cancer Institute of New Jersey
Who cannot join
- Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study
This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT).
II. To collect pilot data on the impact of C-ACT on patients' and partners' anxiety, depression, and quality of life.
OUTLINE:
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
After completion of the study, patients and their partners are followed up at 1 week.
- Conditions
- Malignant Female Reproductive System Neoplasm, Malignant Hepatobiliary Neoplasm, Partner, Stage III Breast Cancer, Stage III Cervical Cancer, Stage III Colorectal Cancer
- Being tested
- Cognitive Behavior Therapy, Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called CBT, cognitive therapy, CT
Undergo ACT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (ACT) | Experimental | Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session. Receives: Behavioral: Cognitive Behavior Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acceptance as measured by the COPE acceptance subscale
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Measured: Baseline to 1-week post intervention
Change in avoidance as measured by the Acceptance and Action Questionnaire-II
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Measured: Baseline to 1-week post intervention
Change in value based living as measured by the Valued Living questionnaire
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Measured: Baseline to 1-week post intervention
Feasibility defined as acceptance
This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%
Measured: Up to 1-week post intervention
Feasibility defined as session drop out
This trial will be considered feasible if drop out from sessions (at any point over the 6 sessions) is less than 20% (thus, 6/30)
Measured: Up to 1-week post intervention
Feasibility defined as survey follow ups
This trial will be considered feasible if 3) completion of study surveys at the follow up is 80%, and patients are not lost to progressive disease.
Measured: Up to 1-week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start6 Dec 2017
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers Cancer Institute of New Jersey
- Investigators
- Sharon Manne, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112668
- Sponsor's protocol ID
- Pro20170000115
- Other IDs
- NCI-2017-00445, Pro20170000115, 131604, P30CA072720
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2017
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT03112668
- Acronym / sponsor ID
- Pro20170000115
- Conditions
- Malignant Female Reproductive System Neoplasm, Malignant Hepatobiliary Neoplasm, Partner, Stage III Breast Cancer, Stage III Cervical Cancer, Stage III Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 13 Apr 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 pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.
Detailed description
PRIMARY OBJECTIVES:
- To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT).
II. To collect pilot data on the impact of C-ACT on patients' and partners' anxiety, depression, and quality of life.
OUTLINE:
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
After completion of the study, patients and their partners are followed up at 1 week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (ACT) | Experimental | Behavioral: Cognitive Behavior Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Survey AdministrationPatients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
- Married or cohabiting with a significant other of either gender for more than one year
- At the time of recruitment, a life expectancy of greater than 6 months and/or a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- English speaking
- No significant hearing impairment that would prevent participation in sessions
Key exclusion criteria (1 listed)
- Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment
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 |
|---|---|---|
| Cognitive Behavior TherapyAlso: CBT, cognitive therapy, CTUndergo ACT | Behavioural | Supportive Care (ACT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (ACT) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (ACT) |
| Survey AdministrationAncillary studies | Other | Supportive Care (ACT) |
Primary outcome
Change in acceptance as measured by the COPE acceptance subscale
Time frame: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Change in avoidance as measured by the Acceptance and Action Questionnaire-II
Time frame: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Change in value based living as measured by the Valued Living questionnaire
Time frame: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Feasibility defined as acceptance
Time frame: Up to 1-week post intervention
This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%
Feasibility defined as session drop out
Time frame: Up to 1-week post intervention
This trial will be considered feasible if drop out from sessions (at any point over the 6 sessions) is less than 20% (thus, 6/30)
Feasibility defined as survey follow ups
Time frame: Up to 1-week post intervention
This trial will be considered feasible if 3) completion of study surveys at the follow up is 80%, and patients are not lost to progressive disease.
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 8 Apr 2021.
Related trials for Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Malignant Uterine Corpus Neoplasm
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.
Sharon Manne principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm and Malignant Hepatobiliary Neoplasm, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 6 inclusion and 1 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 8 Apr 2021. 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 States. 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?
Change in acceptance as measured by the COPE acceptance subscale (time frame: Baseline to 1-week post intervention). The study lists 6 primary outcomes in all. 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 8 Apr 2021.