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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study

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 data supports the effectiveness of the COPE+ treatment for cancer patients with cognitive impairment?

Research shows that cognitive behavioral therapy (CBT), a component of COPE+, can help improve mental health and coping in cancer patients. Studies have found that psychosocial support using CBT techniques can enhance quality of life and reduce anxiety and depression in cancer patients. ^{1 2 3 4 5}

Is the COPE+ Program for Cancer Patients with Cognitive Impairment safe?

Cognitive Behavioral Therapy (CBT) and similar psychological support interventions, like the COPE+ Program, are generally considered safe for humans. Studies have shown that these therapies do not lead to increased health service usage or adverse effects, and they can improve mental health and quality of life in cancer patients. ^{1 2 5 6 7}

How is the COPE+ treatment different from other treatments for cancer patients with cognitive impairment?

COPE+ is unique because it uses Cognitive Behavioral Therapy (CBT), which focuses on changing negative thought patterns to improve mental health, unlike other treatments that may focus solely on cognitive retraining or medication. This approach not only addresses cognitive impairment but also provides psychological support, potentially improving overall quality of life. ^{7 8 9 10 11}

Research Team

Katherine Ramos, Ph.D.

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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 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 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]

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]

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]

References

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

A controlled trial of group cognitive behavior therapy for Irish breast cancer patients. [2018]

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

Telephone-delivered individual cognitive behavioural therapy for cancer patients: An equivalence randomised trial. [2019]

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

Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care. [2013]

4. England 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). [2020]

5. Germany 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. [2020]

6. England 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. [2021]

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

Managing Cancer and Living Meaningfully (CALM) Intervention on Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors. [2021]

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

Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Identification of mild cognitive impairments in cancer survivors. [2013]

10. Germany pubmed.ncbi.nlm.nih.gov

Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. [2023]

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

Changes and Influencing Factors of Cognitive Impairment in Patients with Breast Cancer. [2023]