Early-Stage Breast CancerCanThriveNCT00665899
A Couples Approach to Enhance Breast Cancer Survivorship
A study testing Cancer-Focused Relationship Enhancement and Couple's Cancer Education in people with Early-Stage Breast Cancer, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early-Stage Breast Cancer
- What is being tested?
- Cancer-Focused Relationship Enhancement and Couple's Cancer Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Apr 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with early stage breast cancer within last year
- No history of breast cancer, or other cancers in last 5 years (except skin cancer)
- Living together in a committed heterosexual relationship
- read and speak English
- Agree to participate
Who cannot join
- Stage 3b and above breast cancer
- Notable psychopathology, including severe depression with suicidality
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27708
About this study
The purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. This cancer-focused relationship enhancement intervention adapts well-validated cognitive-behavioral interventions to teach patients and partners specific relationship skills, such as problem-solving skills, communication, and maximizing positive interactions, that they can use in addressing breast cancer. This project's major goals are to improve the patient's individual functioning and specific aspects of the couple's relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and social support). In the current investigation, cancer-focused relationship enhancement will be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual condition.
- Conditions
- Early-Stage Breast Cancer
- Being tested
- Cancer-Focused Relationship Enhancement, Couple's Cancer Education
- Keywords
- breast cancer, couples, cognitive behavioral therapy, Women with early stage breast cancer and their partners.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer-Focused Relationship EnhancementBehavioural
Couples meet individually with a health educator for 6 sessions to learn about ways to support each other and communicate about breast cancer related issues.
Couple's Cancer EducationBehavioural
Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Cancer-Focused Relationship Enhancement | Experimental | Cancer-Focused Relationship Enhancement Receives: Behavioral: Cancer-Focused Relationship Enhancement |
| Couple's Cancer Education | Experimental | Couple's Cancer Education Receives: Behavioral: Couple's Cancer Education |
| Usual Care | No intervention | Cancer-Related Community and Internet Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
Measured: Pre, post, 6 month follow-up, 12 month follow-up
Secondary outcomes (1)
Observational coding of couples social support and decision making conversations
Measured: pre, post, 6 month follow-up, 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJul 2004
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early-Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Donald H Baucom, Ph.D., Principal investigator, University of North Carolina, Chapel HillLaura S Porter, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665899
- Sponsor's protocol ID
- 04-0977
- Other IDs
- 1R01CA107477-01, LCC 0402
- Acronym
- CanThrive
- Status last verified
- Oct 2016
- First submitted
- 22 Apr 2008
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zimmermann T, Heinrichs N, Baucom DH. "Does one size fit all?" moderators in psychosocial interventions for breast cancer patients: a meta-analysis. Ann Behav Med. 2007 Nov-Dec;34(3):225-39. doi: 10.1007/BF02874548.
PubMed 18020933Baucom DH, Porter LS, Kirby JS, Gremore TM, Keefe FJ. Psychosocial issues confronting young women with breast cancer. Breast Dis. 2005-2006;23:103-13. doi: 10.3233/bd-2006-23114.
PubMed 16823173
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couples Approach to Enhance Breast Cancer Survivorship
- ClinicalTrials.gov ID
- NCT00665899
- Acronym / sponsor ID
- CanThrive / 04-0977
- Conditions
- Early-Stage Breast Cancer
- Keywords
- breast cancer, couples, cognitive behavioral therapy, Women with early stage breast cancer and their partners.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Duke University, National Cancer Institute (NCI)
- Study start
- Jul 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Apr 2008 (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 purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. This cancer-focused relationship enhancement intervention adapts well-validated cognitive-behavioral interventions to teach patients and partners specific relationship skills, such as problem-solving skills, communication, and maximizing positive interactions, that they can use in addressing breast cancer. This project's major goals are to improve the patient's individual functioning and specific aspects of the couple's relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and social support). In the current investigation, cancer-focused relationship enhancement will be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer-Focused Relationship Enhancement | Experimental | Behavioral: Cancer-Focused Relationship EnhancementCancer-Focused Relationship Enhancement |
| Couple's Cancer Education | Experimental | Behavioral: Couple's Cancer EducationCouple's Cancer Education |
| Usual Care | No intervention | –Cancer-Related Community and Internet Resources |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with early stage breast cancer within last year
- No history of breast cancer, or other cancers in last 5 years (except skin cancer)
- Living together in a committed heterosexual relationship
- read and speak English
- Agree to participate
Key exclusion criteria (2 listed)
- Stage 3b and above breast cancer
- Notable psychopathology, including severe depression with suicidality
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 |
|---|---|---|
| Cancer-Focused Relationship EnhancementCouples meet individually with a health educator for 6 sessions to learn about ways to support each other and communicate about breast cancer related issues. | Behavioural | Cancer-Focused Relationship Enhancement |
| Couple's Cancer EducationCouples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options. | Behavioural | Couple's Cancer Education |
Primary outcome
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
Time frame: Pre, post, 6 month follow-up, 12 month follow-up
1 secondary outcome
Observational coding of couples social support and decision making conversations
Time frame: pre, post, 6 month follow-up, 12 month 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 27 Oct 2016.
- Background: PubMed 18020933Zimmermann T, Heinrichs N, Baucom DH. "Does one size fit all?" moderators in psychosocial interventions for breast cancer patients: a meta-analysis. Ann Behav Med. 2007 Nov-Dec;34(3):225-39. doi: 10.1007/BF02874548.
- Background: PubMed 16823173Baucom DH, Porter LS, Kirby JS, Gremore TM, Keefe FJ. Psychosocial issues confronting young women with breast cancer. Breast Dis. 2005-2006;23:103-13. doi: 10.3233/bd-2006-23114.
- CanThrive WebsiteLink provided by the sponsor.
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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.
Donald H Baucom, Ph.D. principal investigator
University of North Carolina, Chapel Hill
Laura S Porter, Ph.D. principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer-Focused Relationship Enhancement and Couple's Cancer Education in people with Early-Stage Breast Cancer, run by University of North Carolina, Chapel Hill at 2 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 5 inclusion and 2 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning (time frame: Pre, post, 6 month follow-up, 12 month follow-up). 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 NCT00665899, which also lists 2 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 27 Oct 2016.