Advanced CancerCCST2NCT04590885
Coping Together: Couple-based Interventions for Cancer
A study testing Couple Communication Skills Training and Healthy Lifestyle Information in people with Advanced Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and their spouses/intimate partners. Couples will be randomized 1:1 to receive either the CCST or to an attention control condition (Healthy Living Information; HLI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Couple Communication Skills Training and Healthy Lifestyle Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 31 Dec 2025
- 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
- Married or in a committed intimate relationship
- Diagnosis of one the following advanced cancers: Stage IIIB or IV non-small cell lung cancer or extensive stage small cell lung cancer, Stage III pancreatic cancer or Stage IV GI cancer, Stage IV GU cancer, Stage IV breast cancer and GYN cancer Stage III-IV ovarian, IV uterine, IV cervical.
- Both members of the couple must speak and read English.
- Patient and/or partner scores >=1.0 on the Holding Back screen.
Who cannot join
- Patient lacks capacity for interview (documented diagnosis of active psychosis or dementia) or is unable to provide informed consent as assessed by research staff.
- Patient has a life expectancy < 6 months as estimated by his/her treating oncologist.
- Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.
- Patient or partner is too sick to participate, as judged by the oncologist or research staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Couple Communication Skills Training for Advanced Cancer
The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and their spouses/intimate partners. Couples will be randomized 1:1 to receive either the CCST or to an attention control condition (Healthy Living Information; HLI). We will evaluate CCST effects on a range of patient and partner relationship and psychological outcomes.
Read the detailed description
For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and the couple's collective well-being. Couples' ability to communicate openly and effectively with each other about cancer-related concerns can improve their psychological adjustment and quality of their relationship. Open and effective communication may also lead to better symptom management and goal-concordant care. However, many couples report difficulties communicating about cancer, even in the context of overall satisfying relationships. This can have a number of deleterious consequences, including deficits in emotional support, decreases in intimacy and relationship quality, and increased psychological distress. Thus, interventions designed to facilitate effective communication between cancer patients and their partners are likely to have beneficial effects on both individual and relationship functioning.
Prior research, including studies conducted by our team, has found that couple-based interventions that target communication lead to positive outcomes for cancer patients and their partners. However, most prior studies have been limited by reliance on an in-person treatment delivery format which keeps many couples from participating. In addition, prior studies have not targeted interventions to couples who are most likely to benefit. There is increasing evidence that psychosocial interventions for cancer, including couple-based interventions, should be targeted to those at risk of poor outcomes. Our prior research indicates that couples who report communication difficulties (e.g., high levels of holding back from discussing cancer-related concerns) have increased psychological distress and poorer relationship functioning and are most likely to benefit from a couple communication intervention specifically designed to addressed their communication problems.
The specific aims of this study are (1)To determine whether CCST significantly improves patients' and partners' individual psychological adjustment (i.e., psychological distress, life completion) and patient health and health care outcomes (physical well-being, symptom distress, advance care planning discussions and completion of advance directives, hospitalizations, and emergency department visits) compared to an education condition. (2) To determine whether, for couples receiving the CCST intervention, improvements in psychological adjustment, relationship functioning, and patient health are mediated by improvements in their communication, including objective measures of communication quality and communal coping (e.g., "we-talk") derived from couple conversations and self-reported protective buffering. (3) To examine differences in response to the CCST intervention for patients versus partners, for male versus female participants, and for patients with different cancer diagnoses (breast, lung, GI, GU). (4) To conduct an implementation-related process evaluation of the intervention.
- Conditions
- Advanced Cancer
- Being tested
- Couple Communication Skills Training, Healthy Lifestyle Information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple Communication Skills TrainingBehavioural
Also called CCST
Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
Healthy Lifestyle InformationBehavioural
Also called HLI
Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.
| Study group | Role | What they receive |
|---|---|---|
| Couple Communication and Support | Other | CCST includes components to assist couples in communicating effectively, decreasing avoidance of important cancer-related issues, and providing each other with support. It includes training in skills for sharing one's thoughts and feelings and listening to one's partner and responding in a supportive manner, and joint problem solving. Participants will be asked to participate inactivities at home between sessions to strengthen skills acquisition. Receives: Behavioral: Couple Communication Skills Training |
| Healthy Lifestyle Informaion | Other | Healthy Lifestyle Information provides couples with health information relevant to cancer in a supportive environment. Sessions focus on the following topics: fatigue, sleep disturbance, nutrition, physical activity, survivorship care plans, and palliative care. Patients and partners are invited to discuss their experiences around the session topics with the therapist and ask questions about the information presented. Receives: Behavioral: Healthy Lifestyle Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient relationship functioning
Change in patient relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner relationship functioning
Change in partner relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient relationship functioning
Change in patient intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner relationship functioning
Change in partner intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Secondary outcomes (12)
Changes in patient psychological functioning
Change in patient psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Change in partner psychological distress measured by the Hospital Anxiety and Depression Scale (higher scores indicate higher distress)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient mood as measured by the Positive and Negative Mood Scale (higher scores on the positive and negative mood subscales indicate higher negative and positive mood, respectively)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Change in partner mood as measured by the Positive and Negative Mood Scale (higher scores on the positive and negative mood subscales indicate higher negative and positive mood, respectively)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient life completion measured by the Life Completion scale of the QUAL-E (higher scores indicate higher completion)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Change in partner life completion measured by the Life Completion scale of the QUAL-E Family (higher scores indicate higher completion)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient physical well being as measured by the Physical Well Being subscale of the Functional Assessment of Cancer Therapy scale (higher scores indicate higher physical well being)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient and partner psychological functioning
Change in symptom distress as measured by the Condensed Memorial Symptom Assessment Scale (higher scores indicate higher symptom distress)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient advance care planning discussions (presence or absence, via patient self-report)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient completion of advanced directives (presence or absence, via patient self-report)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient hospitalizations (number of hospitalizations per patient self-report, validated by medical record review)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Change in patient emergency department visits (number of emergency department visits per patient self-report, validated by medical record review)
Measured: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Oct 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 Advanced CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Porter, PhD, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590885
- Sponsor's protocol ID
- Pro00103232
- Acronym
- CCST2
- Status last verified
- Dec 2025
- First submitted
- 9 Oct 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porter LS, Ramos K, Baucom DH, Steinhauser K, Erkanli A, Strauman TJ, Zafar SY, Check DK, Leo K, Liu E, Keefe FJ. Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial. Trials. 2022 Aug 26;23(1):712. doi: 10.1186/s13063-022-06656-4.
PubMed 36028908
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple Communication Skills Training for Advanced Cancer
- ClinicalTrials.gov ID
- NCT04590885
- Acronym / sponsor ID
- CCST2 / Pro00103232
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Oct 2020 (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.
The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and their spouses/intimate partners. Couples will be randomized 1:1 to receive either the CCST or to an attention control condition (Healthy Living Information; HLI). We will evaluate CCST effects on a range of patient and partner relationship and psychological outcomes.
Detailed description
For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and the couple's collective well-being. Couples' ability to communicate openly and effectively with each other about cancer-related concerns can improve their psychological adjustment and quality of their relationship. Open and effective communication may also lead to better symptom management and goal-concordant care. However, many couples report difficulties communicating about cancer, even in the context of overall satisfying relationships. This can have a number of deleterious consequences, including deficits in emotional support, decreases in intimacy and relationship quality, and increased psychological distress. Thus, interventions designed to facilitate effective communication between cancer patients and their partners are likely to have beneficial effects on both individual and relationship functioning.
Prior research, including studies conducted by our team, has found that couple-based interventions that target communication lead to positive outcomes for cancer patients and their partners. However, most prior studies have been limited by reliance on an in-person treatment delivery format which keeps many couples from participating. In addition, prior studies have not targeted interventions to couples who are most likely to benefit. There is increasing evidence that psychosocial interventions for cancer, including couple-based interventions, should be targeted to those at risk of poor outcomes. Our prior research indicates that couples who report communication difficulties (e.g., high levels of holding back from discussing cancer-related concerns) have increased psychological distress and poorer relationship functioning and are most likely to benefit from a couple communication intervention specifically designed to addressed their communication problems.
The specific aims of this study are (1)To determine whether CCST significantly improves patients' and partners' individual psychological adjustment (i.e., psychological distress, life completion) and patient health and health care outcomes (physical well-being, symptom distress, advance care planning discussions and completion of advance directives, hospitalizations, and emergency department visits) compared to an education condition. (2) To determine whether, for couples receiving the CCST intervention, improvements in psychological adjustment, relationship functioning, and patient health are mediated by improvements in their communication, including objective measures of communication quality and communal coping (e.g., "we-talk") derived from couple conversations and self-reported protective buffering. (3) To examine differences in response to the CCST intervention for patients versus partners, for male versus female participants, and for patients with different cancer diagnoses (breast, lung, GI, GU). (4) To conduct an implementation-related process evaluation of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple Communication and Support | Other | Behavioral: Couple Communication Skills TrainingCCST includes components to assist couples in communicating effectively, decreasing avoidance of important cancer-related issues, and providing each other with support. It includes training in skills for sharing one's thoughts and feelings and listening to one's partner and responding in a supportive manner, and joint problem solving. Participants will be asked to participate inactivities at home between sessions to strengthen skills acquisition. |
| Healthy Lifestyle Informaion | Other | Behavioral: Healthy Lifestyle InformationHealthy Lifestyle Information provides couples with health information relevant to cancer in a supportive environment. Sessions focus on the following topics: fatigue, sleep disturbance, nutrition, physical activity, survivorship care plans, and palliative care. Patients and partners are invited to discuss their experiences around the session topics with the therapist and ask questions about the information presented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Married or in a committed intimate relationship
- Diagnosis of one the following advanced cancers: Stage IIIB or IV non-small cell lung cancer or extensive stage small cell lung cancer, Stage III pancreatic cancer or Stage IV GI cancer, Stage IV GU cancer, Stage IV breast cancer and GYN cancer Stage III-IV ovarian, IV uterine, IV cervical.
- Both members of the couple must speak and read English.
- Patient and/or partner scores >=1.0 on the Holding Back screen.
Key exclusion criteria (4 listed)
- Patient lacks capacity for interview (documented diagnosis of active psychosis or dementia) or is unable to provide informed consent as assessed by research staff.
- Patient has a life expectancy < 6 months as estimated by his/her treating oncologist.
- Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.
- Patient or partner is too sick to participate, as judged by the oncologist or research staff.
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 |
|---|---|---|
| Couple Communication Skills TrainingAlso: CCSTParticipants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication. | Behavioural | Couple Communication and Support |
| Healthy Lifestyle InformationAlso: HLIParticipants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics. | Behavioural | Healthy Lifestyle Informaion |
Primary outcome
Changes in patient relationship functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Change in patient relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)
Changes in partner relationship functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Change in partner relationship satisfaction measured by the Couples Satisfaction Inventory (higher scores indicate higher satisfaction)
Changes in patient relationship functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Change in patient intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)
Changes in partner relationship functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Change in partner intimacy as measured by the Miller Social Intimacy Scale (higher scores indicate higher intimacy)
12 secondary outcomes
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in partner psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient and partner psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up
Changes in patient psychological functioning
Time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention 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 20 Jan 2026.
- Derived from this study: PubMed 36028908Porter LS, Ramos K, Baucom DH, Steinhauser K, Erkanli A, Strauman TJ, Zafar SY, Check DK, Leo K, Liu E, Keefe FJ. Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial. Trials. 2022 Aug 26;23(1):712. doi: 10.1186/s13063-022-06656-4.
- Individual participant dataSharing planned: No
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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.
Laura Porter, PhD principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple Communication Skills Training and Healthy Lifestyle Information in people with Advanced Cancer, run by Duke University 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 4 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: finished, as of the sponsor's last update on 20 Jan 2026. 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?
Changes in patient relationship functioning (time frame: Baseline, end of intervention (up to 8 months), 3 month post intervention follow-up). The study lists 4 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 NCT04590885, 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 20 Jan 2026.