Couple-based Interventions for Cancer

(CCST2 Trial)

Overseen By Laura Porter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Psychosis, Dementia, Life expectancy < 6 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how couples can better communicate and support each other when one partner has advanced cancer. It compares two approaches: Couple Communication Skills Training, which helps couples discuss cancer-related issues and support each other, and a program offering general healthy living tips. The goal is to determine if the communication training improves relationships and psychological well-being for both patients and their partners. Couples qualify if one partner has certain advanced cancers and both can speak and read English. Participants should also be able to use a computer or videoconferencing for the sessions. As an unphased trial, this study provides couples the chance to enhance their relationship and emotional well-being through innovative communication strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Couple Communication Skills Training intervention is safe for couples dealing with cancer?

Research shows that Couple Communication Skills Training (CCST) is generally manageable for participants. Previous studies have found that this training helps couples discuss important cancer-related topics without significant negative effects. Participants have reported improved communication and support, indicating the training's safety and effectiveness.

For the Healthy Lifestyle Information treatment, studies indicate that adopting a healthy lifestyle is linked to positive health outcomes without harmful effects. Following healthy habits can lower cancer risk and improve survival rates.

Both treatments in this trial are non-invasive and focus on enhancing communication and lifestyle habits. They do not involve medication or physical procedures, reducing the risk of harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Couple Communication Skills Training (CCST) because it focuses on improving how couples talk about and support each other through the cancer journey, which is often overlooked in traditional treatments. Unlike standard care that mainly addresses physical symptoms with medication or therapy, CCST emphasizes emotional and relational health, teaching couples how to effectively express thoughts and feelings, listen, and solve problems together. This innovative approach aims to reduce stress and avoidance of important cancer-related issues, potentially improving overall well-being for both the patient and their partner.

What evidence suggests that the Couple Communication Skills Training is effective for improving relationship and psychological outcomes in cancer patients and their partners?

In this trial, participants will join one of two groups. Research has shown that Couple Communication Skills Training (CCST), one of the interventions, can improve relationships for cancer patients and their partners. By focusing on communication, couples can better support each other, reducing stress and strengthening their bond. This training includes exercises to help couples share thoughts and listen effectively, leading to greater relationship satisfaction. Previous research highlights that these couple-based programs often yield positive results in managing cancer-related challenges.

For those in the Healthy Lifestyle Information group, another intervention, living a healthy lifestyle has been linked to better survival rates and fewer cancer-related issues. Studies suggest that eating well, staying active, and adopting other healthy habits can lower cancer risk and improve the quality of life for survivors. These lifestyle changes have significantly impacted health outcomes for people living with cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Laura Porter, PhD

Principal Investigator

Duke

Are You a Good Fit for This Trial?

This trial is for couples where one partner has advanced cancer (specific types like certain stages of lung, pancreatic, GI, GU, or breast cancer) and they both speak English. They must be in a committed relationship and willing to discuss their feelings openly. Couples can't join if the patient's life expectancy is less than 6 months, either is too ill to participate or use a computer/videoconferencing.

Inclusion Criteria

Both members of the couple must speak and read English.

You or your partner have a score of 1.0 or higher on the Holding Back screen.

I am married or in a committed relationship.

Exclusion Criteria

Your doctor believes you have less than 6 months to live.

Patient or partner is physically impaired in such a way that precludes the use of a computer or videoconferencing.

I am unable to participate in an interview or give informed consent due to a mental health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Couples receive either the Couple Communication Skills Training (CCST) or Healthy Living Information (HLI) intervention

8 months

Sessions conducted virtually or in-person

Follow-up

Participants are monitored for changes in psychological and relationship functioning

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Couple Communication Skills Training
• Healthy Lifestyle Information

Trial Overview The study tests Couple Communication Skills Training (CCST) against Healthy Living Information (HLI). It aims to see how CCST affects relationships and mental health in patients with advanced cancer and their partners. Participants are randomly placed into two groups: one receives CCST while the other gets HLI.

How Is the Trial Designed?

Group I: Healthy Lifestyle Informaion Experimental Treatment 1 Intervention

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.

Group II: Couple Communication and Support Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Couples facing cancer who had communication issues or distress before participating in couple-based communication interventions showed significant improvements in relationship functioning, including better communication, intimacy, and overall relationship satisfaction.

These interventions also led to positive individual outcomes, such as reduced anxiety and depression, improved psychological adjustment, and enhanced quality of life for both partners, highlighting the importance of effective communication in coping with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple-Based Communication Interventions for Cancer Patient-Spousal Caregiver Dyads' Psychosocial Adaptation to Cancer: A Systematic Review. Zhou, J., Chen, X., Wang, Z., et al.[2023]

The study evaluates the effectiveness of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples dealing with advanced cancer, specifically targeting those who struggle to discuss cancer-related concerns, which can lead to poorer psychological and relationship outcomes.

Involving 230 patients with various types of advanced cancer and their partners, the trial aims to improve relationship functioning and psychological well-being, while also assessing communication behaviors as potential mediators of treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial. Porter, LS., Ramos, K., Baucom, DH., et al.[2022]

The couple-based supportive communication (CSC) intervention for head and neck cancer patients was highly feasible, with 98% of sessions completed and couples expressing high satisfaction with the program.

Patients and their partners who participated in the CSC reported significant improvements in both individual and relationship functioning compared to those receiving standard treatment, suggesting that enhancing emotional disclosure and support can be beneficial during oncology treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple-based communication intervention for head and neck cancer: a randomized pilot trial. Gremore, TM., Brockstein, B., Porter, LS., et al.[2021]

The Couple Skills Training intervention significantly reduced fear of cancer recurrence (FCR) and improved cancer-related communication among 90 young breast cancer patients and their spouses, with results showing strong statistical significance (p < 0.001).

Three months post-intervention, couples in the training group also reported increased levels of hope, indicating that this intervention not only addresses immediate concerns but also fosters long-term emotional support for both patients and their spouses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couples' skills training intervention in young breast cancer patients with fear of cancer recurrence: A randomized controlled trial. Cheng, Y., Xiong, M., Li, Y., et al.[2023]

The Couple Communication Scale (CCS) has been validated for use in German-speaking patients with advanced cancer, demonstrating excellent internal consistency (Cronbach's α=0.91) and a one-factor structure that explains a significant portion of variance in communication items.

The CCS is negatively associated with attachment insecurity, anxiety, and depression, indicating that better communication in couples may correlate with lower levels of these psychological symptoms in patients facing advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of Couples' Communication in Patients with Advanced Cancer: Validation of a German Version of the Couple Communication Scale (CCS)]. Conrad, M., Engelmann, D., Friedrich, M., et al.[2022]

In a study of 147 breast cancer patients and 127 partners, mutual constructive communication was linked to lower psychological distress and higher relationship satisfaction for both partners during and after treatment.

Conversely, demand-withdraw communication led to increased distress and lower relationship satisfaction, highlighting the importance of effective communication strategies in managing stress during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related relationship communication in couples coping with early stage breast cancer. Manne, SL., Ostroff, JS., Norton, TR., et al.[2015]

The Couplelinks intervention, designed for young women with breast cancer and their male partners, was found to be generally acceptable and beneficial, with 10 out of 16 couples completing the entire program and reporting enhanced communication and relationship closeness.

However, some couples struggled to complete the program due to disruptions in their routine, particularly those facing higher levels of relational or illness-related distress, indicating a need for tailored support for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of an online intervention to support young couples' coping and adjustment to breast cancer. Fergus, KD., McLeod, D., Carter, W., et al.[2014]

The study aims to compare two models of couple communication—social-cognitive processing (SCP) and relationship intimacy (RI)—to understand their impact on psychological and relationship adjustment in cancer patients and their partners over one year.

Using a comprehensive approach that includes self-report questionnaires, real-time assessments via smartphones, and laboratory observations, the research will provide insights into effective communication strategies that can enhance the well-being of both patients and their significant others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple Communication in Cancer: Protocol for a Multi-Method Examination. Langer, SL., Romano, JM., Keefe, F., et al.[2023]

Open communication between couples in the context of oncology is linked to better psychological and relational wellbeing, while avoiding communication has negative effects; however, the benefits of disclosure depend on factors like partner responsiveness and personal characteristics.

The review highlights a lack of consensus on how to define and assess communication behaviors, suggesting that future research should focus on understanding effective partner responses and the timing and topics of disclosure to improve clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond "being open about it": A systematic review on cancer related communication within couples. Hasson-Ohayon, I., Goldzweig, G., Braun, M., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36028908/

Evaluating a couple communication skills training (CCST ... Methods: This RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome).

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06656-4

Evaluating a couple communication skills training (CCST ... This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of ...

3. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA229425

Couple Communication Skills Training for Advanced Cancer Prior research has found that couple-based interventions that target communication lead to positive outcomes for cancer patients and their partners. However ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04590885

Coping Together: Couple-based Interventions for Cancer The objective of the proposed study is to evaluate the Couple Communication Skills Training (CCST) intervention in 250 patients with advanced cancer and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388925000225

Efficacy of couple-based dyadic interventions on the ... For patients with cancer, supportive care demonstrated the largest effect size in improving couples' relationships (standardized mean difference [SMD]: -0.69; ...

6. reporter.nih.gov reporter.nih.gov/project-details/10759377

Couple Communication Skills Training for Advanced Cancer This study will test the effects of an intervention designed to enhance couples' ability to communicate effectively about important cancer-related concerns, ...