COPE+ Program for Cancer Patients with Cognitive Impairment

Overseen By Kaylee Faircloth

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Dementia, Untreated psychiatric illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Up to 17 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether video-conference sessions can assist cancer patients with mild memory issues and their caregivers. The program, COPE+, involves both the patient and a family member or spouse collaborating in these sessions. The researchers aim to determine if this approach can improve the well-being of families managing cancer and memory concerns. Individuals aged 65 or older with breast, colon, rectal, or lung cancer and mild cognitive issues might be suitable, particularly if they have a caregiver who spends significant time with them. Conducted online, the study requires participants to be comfortable using a tablet for video calls. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for cancer patients and their caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the COPE+ program is safe for cancer patients with cognitive impairment?

Research has shown that cognitive-behavioral therapy (CBT), a key part of the COPE+ program, is generally safe for people, including those with cancer. Studies have found that CBT can help cancer patients feel less tired and more resilient, aiding them in handling stress and challenges better.

No serious safety concerns are known with CBT. As a non-drug treatment, it avoids the side effects associated with medications. Participants in past studies generally handled it well, reporting no major problems or side effects.

Overall, available research suggests that the COPE+ program, which includes CBT, is safe for cancer patients with mild memory issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPE+ program because it offers a fresh approach to helping cancer patients with mild cognitive impairment. Unlike traditional treatments that often focus solely on medical interventions, COPE+ integrates cognitive and emotional support by actively involving both patients and their caregivers. This dual focus not only aims to improve cognitive function but also enhances overall quality of life, providing a supportive environment for both parties. By addressing the emotional and cognitive needs of patients and their caregivers, COPE+ has the potential to offer a more holistic way of managing cognitive challenges in cancer care.

What evidence suggests that the COPE+ program is effective for cancer patients with cognitive impairment?

Research has shown that cognitive behavioral therapy (CBT) benefits cancer patients by enhancing mental health and quality of life. One study found that CBT moderately improved mental health and overall quality of life for these patients, addressing specific issues like sleep disturbances and fatigue. Another study discovered that CBT increased resilience, the ability to recover from challenges. Additionally, CBT reduced anxiety and depression in cancer patients. This evidence suggests that COPE+, based on CBT principles, could effectively address cognitive concerns in cancer patients. In this trial, participants will receive the COPE+ program, designed to support both patients and their caregivers. ^{2 6 7 8 9}

Who Is on the Research Team?

Katherine Ramos, Ph.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with Stage I-IV breast, colon, rectal, or lung cancer diagnosed within the last two years. They must have mild cognitive issues and live at home with a family caregiver who spends 3-4 hours daily providing care. Both must speak English and be able to use a tablet for video calls. Excluded are those with serious untreated mental illness, dementia without capacity to participate, or insufficient distress levels.

Inclusion Criteria

Not exhibit cognitive impairment

Have an informal family caregiver

Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions

Exclusion Criteria

I have dementia and cannot make decisions for myself.

I do not have severe visual or hearing impairments that would stop me from participating.

Have a serious untreated psychiatric illness as documented in medical chart review

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants and their caregivers engage in six, 60-minute video-conference sessions

Up to 17 weeks

6 video-conference sessions

Follow-up

Participants are monitored for changes in relationship satisfaction, distress, quality of life, and communication patterns

1 month

1 assessment

What Are the Treatments Tested in This Trial?

Interventions

• COPE +

Trial Overview The study tests a program called COPE+ involving patients with cancer and mild memory problems along with their caregivers (dyads). They'll attend six one-hour video sessions via an iPad provided by the researchers. The goal is to assess if this dyadic intervention helps manage their conditions.

How Is the Trial Designed?

Group I: Patient Caregiver Dyad Experimental Treatment 1 Intervention

Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study of 114 cancer survivors, internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of anxiety and depression compared to treatment-as-usual, with a large effect size (Hedges g = 1.51).

Participants in the iCBT group also experienced lower general distress, reduced fear of cancer recurrence, and improved quality of life, indicating that this therapy is an effective and efficient option for managing mental health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). Murphy, MJ., Newby, JM., Butow, P., et al.[2020]

Cognitive impairment is prevalent among breast cancer patients after chemotherapy, with significant deficits observed in areas such as working memory, attention, and social cognition, as assessed in a study of 172 patients using the MATRICS Consensus Cognitive Battery.

Factors such as education level, number of chemotherapy sessions, and monthly income were found to influence cognitive function, suggesting that targeted interventions could help improve cognitive outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes and Influencing Factors of Cognitive Impairment in Patients with Breast Cancer. Cui, H., Shi, X., Song, X., et al.[2023]

In a study involving 206 adult patients with advanced cancer, both the CALM therapy and a supportive psycho-oncological counselling intervention (SPI) led to significant reductions in depressive symptoms over 6 months, as measured by the BDI-II and PHQ-9 scales.

However, there was no significant difference in the severity of depression between the CALM and SPI groups, indicating that while both interventions were effective, CALM therapy did not outperform the standard supportive counselling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial. Mehnert, A., Koranyi, S., Philipp, R., et al.[2021]

The Montreal Cognitive Assessment (MoCA) is a feasible tool for identifying mild cognitive impairment in cancer survivors, as demonstrated in a study with 38 participants.

Out of the 38 cancer survivors assessed, 14 scored below the cutoff of 26 on the MoCA, indicating a significant prevalence of mild cognitive impairment among this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of mild cognitive impairments in cancer survivors. Baxter, MF., Dulworth, AN., Smith, TM.[2013]

Telephone-Delivered Cognitive Behavioural Therapy (T-CBT) is as effective as traditional face-to-face Cognitive Behavioural Therapy (TAU-CBT) for cancer patients with high psychological needs, showing significant improvements in anxiety, depression, and cancer concerns after therapy.

Both T-CBT and TAU-CBT led to a reduction in stress and worry, indicating that patients can choose their preferred method of therapy without compromising mental health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-delivered individual cognitive behavioural therapy for cancer patients: An equivalence randomised trial. Watson, M., White, C., Lynch, A., et al.[2019]

A systematic review of 31 studies found that various interventions, such as cognitive behavioral therapy and brain training, show promise in improving cognitive function in cancer patients experiencing cognitive impairment after chemotherapy.

The study highlighted inconsistencies in outcome measurements across different interventions, suggesting a need for standardized assessment tools in future research to better evaluate the effectiveness of these cognitive enhancement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. Oldacres, L., Hegarty, J., O'Regan, P., et al.[2023]

The Finding My Way (FMW) online intervention for cancer survivors showed significant improvements in emotional functioning at 3 months and reduced health service utilization immediately after the intervention, indicating potential short-term benefits for participants.

However, while both the FMW and control groups experienced reductions in cancer-related distress, there were no significant differences between the groups over time, suggesting that the FMW intervention may not provide long-term advantages beyond its active use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors. Beatty, L., Kemp, E., Coll, JR., et al.[2020]

A study involving 74 adults with cancer-related cognitive impairment showed that the Cognitive Retraining and Functional Treatment (CRAFT) program, which combines cognitive training and occupation-based treatment, significantly improved participation in daily life and cognitive performance compared to standard treatment.

CRAFT not only enhanced cognitive outcomes but also led to greater treatment satisfaction and maintained these benefits at a 3-month follow-up, indicating its potential as an effective intervention for improving quality of life in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Maeir, T., Makranz, C., Peretz, T., et al.[2023]

A study involving 179 primary breast cancer patients showed that psychosocial support interventions by trained nurses or psychologists significantly improved quality of life and reduced symptoms like insomnia and dyspnea compared to standard care.

Patients receiving the psychosocial support reported less need for additional hospital psychosocial services, suggesting that this intervention could be an effective and practical alternative in routine cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care. Arving, C., Sjödén, PO., Bergh, J., et al.[2013]

The CALM intervention significantly improved cognitive function, reduced psychological distress, and enhanced quality of life in 74 Chinese breast cancer survivors compared to the usual care group, as measured by various assessment tools.

There was a strong positive correlation between cognitive function and quality of life both before and after the CALM treatment, suggesting that improving cognitive function may also enhance overall well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cancer and Living Meaningfully (CALM) Intervention on Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors. Ding, K., Zhang, X., Zhao, J., et al.[2021]

A 6-week cognitive behavioral therapy (CBT) program for early-stage breast cancer patients did not show significant improvements in coping, quality of life, or mood compared to an educational control group, based on assessments of 69 women.

However, patients who completed the CBT program reported significant improvements in problem severity and the impact of problems, with these gains maintained at a 6-month follow-up, suggesting potential benefits for specific issues despite overall limited effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of group cognitive behavior therapy for Irish breast cancer patients. McKiernan, A., Steggles, S., Guerin, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11336377/

The efficacy of cognitive behavioral therapy for mental health ... Across 132 clinical trials and 1030 effect size estimates, we identified that CBT moderately improves MH and QoL in cancer patients d = 0.388, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842822001330

Effectiveness of cognitive behavioral therapy in improving ... Cognitive behavioral therapy (CBT) improves functional health in cancer survivors. · CBT has the strongest treatment effect on insomnia, followed by fatigue.

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.1030630/full

The efficacy of cognitive behavioral therapy for cancer Cognitive behavioral therapy (CBT) is one of the most recognized psychological interventions to improve the overall quality of life of cancer survivors.

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06628-3

Effects of cognitive behavioral therapy on resilience among ... The results of this study indicate CBT can improve resilience among cancer patients. These findings underscore the importance of considering ...

5. nature.com nature.com/articles/s41598-022-25068-7

Cognitive behavioral therapy for anxiety and depression in ... The pooled results suggested that CBT also significantly improved the anxiety scores of the patients with cancer after intervention and at the 6 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748919303219

Nonpharmacological interventions for cancer-related ... This network meta-analysis found that meditation interventions, cognitive training, cognitive rehabilitation, and exercise were the most effective interventions ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)35403-1/fulltext

Cognitive behavioral therapy or graded exercise ... Among advanced cancer patients with severe fatigue during treatment, a CBT intervention was more effective than usual care for reducing fatigue.

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04026048

Online Treatment of Cognitive Impairment and Insomnia in ... The investigators will conduct a randomized controlled trial of immediate treatment with CBT-I compared to a delayed treatment group with 124 cancer survivors ...