Breast CancerNCT00940277
Couple-Focused Intervention for Breast Cancer Patients
A study testing Group Counseling in people with Breast Cancer, run by Fox Chase Cancer Center at 5 sites in United States.
Trial summary
The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Group Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2007to Oct 2015
- 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
- patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
- patient has had breast cancer surgery within the last twelve months
- patient and partner married or cohabitating
- patient and partner 18 years of age or older
- patient and partner speak and read English
- patient and partner can provide meaningful informed consent
- patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions
- couple lives within 2 hour commuting distance to the center from which they are recruited
Who cannot join
- patient is male
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19001
Christiana Care Health System
Newark, Delaware, 19713
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Cooper Health System
Voorhees Township, New Jersey, 08043
Virtua Health System
Voorhees Township, New Jersey, 08043
About this study
Official title: Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer
The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.
The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.
The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.
- Conditions
- Breast Cancer
- Being tested
- Group Counseling
- Keywords
- women couples counseling groups support intervention marriage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CounselingBehavioural
Group counseling
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Couples Group | Experimental | Enhanced Couples Group: consists of eight 90-minute sessions, conducted weekly. ECG has a didactic educational content presented by the group leader or practice of specific relationship communication, relationship support, and couple-focused stress management. ECG participants are also given instruction about what types of behaviors are unsupportive and training in how to not behave in an unsupportive manner. Receives: Behavioral: Group Counseling |
| Support Group | Experimental | Support Group: 8 weekly 90-minute group counseling sessions. Using a standard approach to supportive therapy, the group interventionists will focus on encouraging participants to share their experiences with cancer, express their emotions related to the experience, voice problems they have in coping with the cancer, and offer support and advice to other members of the group. The co-facilitators will facilitate expression of affect and the sharing of the group's common issues related to cancer. Each session has a broad topic for discussion. Topics include communication with health care providers, issues related to occupational life, and coping with medical procedures and treatment. No formal or didactic information will be provided. Receives: Behavioral: Group Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Inventory
Measured: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
Impact of Events Scale-Revised
Measured: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
Well-being Subscale of the Mental Health Inventory (MHI)
Measured: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Secondary outcomes (3)
Mental Outcomes Survey (MOS SF-36)
Measured: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Adherence to Chemotherapy
Measured: 1 yr follow-up
Adherence to Radiation Therapy
Measured: 1 yr follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startDec 2007
- Primary completionOct 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services, Abington Memorial Hospital, Albert Einstein College of Medicine, Cooper Norcross Health, Virtua Health, City University of New York, School of Public Health, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sharon L Manne, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940277
- Sponsor's protocol ID
- CA-65727
- Other IDs
- R01CA078084-07, IRB#07-831
- Status last verified
- Feb 2016
- First submitted
- 14 Jul 2009
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manne S, Kashy DA, Siegel S, Myers Virtue S, Heckman C, Ryan D. Unsupportive partner behaviors, social-cognitive processing, and psychological outcomes in couples coping with early stage breast cancer. J Fam Psychol. 2014 Apr;28(2):214-24. doi: 10.1037/a0036053. Epub 2014 Mar 10.
PubMed 24611691Manne SL, Siegel S, Kashy D, Heckman CJ. Cancer-specific Relationship Awareness, Relationship Communication, and Intimacy Among Couples Coping with Early Stage Breast Cancer. J Soc Pers Relat. 2014 May;31(3):314-334. doi: 10.1177/0265407513494950.
PubMed 25242854Manne, S. & Ostroff, J. (2011). Couple-focused group intervention for women diagnosed with early stage breast cancer and their partners. In. D. Kissane & M Watson (Eds.), IPOS Academy Handbook of Psychotherapies in Cancer Care. (pp. 129-139). Chichester, UK: Wiley.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00940277
- Acronym / sponsor ID
- CA-65727
- Conditions
- Breast Cancer
- Keywords
- women couples counseling groups support intervention marriage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Christiana Care Health Services, Abington Memorial Hospital, Albert Einstein College of Medicine, Cooper Norcross Health, Virtua Health, City University of New York, School of Public Health, National Cancer Institute (NCI)
- Study start
- Dec 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jul 2009 (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.
The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.
The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.
The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Couples Group | Experimental | Behavioral: Group CounselingEnhanced Couples Group: consists of eight 90-minute sessions, conducted weekly. ECG has a didactic educational content presented by the group leader or practice of specific relationship communication, relationship support, and couple-focused stress management. ECG participants are also given instruction about what types of behaviors are unsupportive and training in how to not behave in an unsupportive manner. |
| Support Group | Experimental | Behavioral: Group CounselingSupport Group: 8 weekly 90-minute group counseling sessions. Using a standard approach to supportive therapy, the group interventionists will focus on encouraging participants to share their experiences with cancer, express their emotions related to the experience, voice problems they have in coping with the cancer, and offer support and advice to other members of the group. The co-facilitators will facilitate expression of affect and the sharing of the group's common issues related to cancer. Each session has a broad topic for discussion. Topics include communication with health care providers, issues related to occupational life, and coping with medical procedures and treatment. No formal or didactic information will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
- patient has had breast cancer surgery within the last twelve months
- patient and partner married or cohabitating
- patient and partner 18 years of age or older
- patient and partner speak and read English
Key exclusion criteria (1 listed)
- patient is male
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 CounselingGroup counseling | Behavioural | Enhanced Couples Group, Support Group |
Primary outcome
Mental Health Inventory
Time frame: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
Impact of Events Scale-Revised
Time frame: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
Well-being Subscale of the Mental Health Inventory (MHI)
Time frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
3 secondary outcomes
Mental Outcomes Survey (MOS SF-36)
Time frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Adherence to Chemotherapy
Time frame: 1 yr follow-up
Adherence to Radiation Therapy
Time frame: 1 yr follow-up
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 3 Feb 2016.
- Results publication: PubMed 24611691Manne S, Kashy DA, Siegel S, Myers Virtue S, Heckman C, Ryan D. Unsupportive partner behaviors, social-cognitive processing, and psychological outcomes in couples coping with early stage breast cancer. J Fam Psychol. 2014 Apr;28(2):214-24. doi: 10.1037/a0036053. Epub 2014 Mar 10.
- Results publication: PubMed 25242854Manne SL, Siegel S, Kashy D, Heckman CJ. Cancer-specific Relationship Awareness, Relationship Communication, and Intimacy Among Couples Coping with Early Stage Breast Cancer. J Soc Pers Relat. 2014 May;31(3):314-334. doi: 10.1177/0265407513494950.
- Results publicationManne, S. & Ostroff, J. (2011). Couple-focused group intervention for women diagnosed with early stage breast cancer and their partners. In. D. Kissane & M Watson (Eds.), IPOS Academy Handbook of Psychotherapies in Cancer Care. (pp. 129-139). Chichester, UK: Wiley.
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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.
Sharon L Manne, PhD principal investigator
Fox Chase Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Counseling in people with Breast Cancer, run by Fox Chase Cancer Center at 5 sites 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 8 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 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Mental Health Inventory (time frame: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention). The study lists 3 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 NCT00940277, which also lists 3 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 3 Feb 2016.