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

460 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Couple Communication Skills Training, Healthy Lifestyle Information for cancer patients?

Research shows that couple-based communication interventions can improve relationship satisfaction and reduce anxiety and depression in cancer patients and their partners. These interventions help couples communicate better, which can lead to better psychological adjustment and quality of life. ^{1 2 3 4 5}

Is couple-based communication intervention safe for cancer patients and their partners?

The studies reviewed did not report any safety concerns related to couple-based communication interventions for cancer patients and their partners. Participants generally found these interventions beneficial for improving communication and relationship satisfaction. ^{1 2 6 7 8}

How does Couple Communication Skills Training differ from other treatments for cancer?

Couple Communication Skills Training is unique because it focuses on improving communication between cancer patients and their partners, which can enhance their psychological adjustment and relationship satisfaction. Unlike other treatments that may focus solely on the patient, this approach addresses the couple as a unit, aiming to reduce anxiety and depression by fostering open discussions about cancer-related concerns. ^{1 2 7 8 9}

Research Team

Laura Porter, PhD

Principal Investigator

Duke

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Couple-Based Communication Interventions for Cancer Patient-Spousal Caregiver Dyads' Psychosocial Adaptation to Cancer: A Systematic Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial. [2022]

3. Germany 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)]. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Couple-based communication intervention for head and neck cancer: a randomized pilot trial. [2021]

5. Scotland pubmed.ncbi.nlm.nih.gov

Couples' skills training intervention in young breast cancer patients with fear of cancer recurrence: A randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Development and pilot testing of an online intervention to support young couples' coping and adjustment to breast cancer. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Beyond "being open about it": A systematic review on cancer related communication within couples. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Cancer-related relationship communication in couples coping with early stage breast cancer. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Couple Communication in Cancer: Protocol for a Multi-Method Examination. [2023]