COPE+ Program for Cancer Patients with Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Dementia, Untreated psychiatric illness, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
12567How 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.
7891011Eligibility 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
+6 more
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
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Patient Caregiver DyadExperimental Treatment1 Intervention
Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
A controlled trial of group cognitive behavior therapy for Irish breast cancer patients. [2018]The aim of this study was to evaluate a manualized cognitive behavioral group intervention for early-stage breast cancer patients. Sixty-nine women were recruited at an Irish specialist oncology hospital and assigned to a 6-week cognitive behavior therapy (CBT) program or an educational control group. Participants were assessed at baseline, 6 weeks, and 6-month follow-up. Groups x Time (2 x 3) ANOVAs showed that the program did not lead to greater improvement on standardized measures of coping, quality of life, or mood compared with the control group. Regression analyses showed that maladaptive coping and distress at baseline were predictive of psychological adjustment at follow-up. Level of distress was also predictive of quality of life at follow-up. Repeated measures ANOVAs of data from cases in the intervention group showed that patients who completed the program showed significant improvement in problem severity, impact of problems, coping ability, and goal attainment from pre- to posttreatment, and these gains were maintained at follow-up for problem severity and impact of problems, but not for coping ability or goal attainment. Participation in the program did not lead to less health service usage during the period from baseline to follow-up, compared with the educational control group. A controlled trial provided limited evidence for the effectiveness of brief cognitive behavior intervention in enhancing psychological adjustment of early-stage breast cancer patients with nonclinically significant levels of psychological distress. Future research should evaluate the effectiveness of the program for patients with elevated levels of psychological distress and limited coping resources.
Telephone-delivered individual cognitive behavioural therapy for cancer patients: An equivalence randomised trial. [2019]To evaluate Telephone-Delivered Cognitive Behavioural Therapy (T-CBT) compared to CBT face to face treatment as usual (TAU-CBT), in cancer patients with high psychological needs, in terms of mental health and coping.
Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care. [2013]In a prospective, randomized study, an individual psychosocial support intervention performed by specially trained oncology nurses, or psychologists, were compared with standard care. Consecutive primary breast cancer patients about to start adjuvant therapy (n = 179) were included. Data were supplied by the questionnaires European Organisation for Research and Treatment of Cancer Quality of Life Study Group Core Quality of life questionnaire with 30 questions (EORTC QLQ-C30) and Breast Cancer Module with 23 questions (BR23), the Hospital Anxiety and Depression Scale, Spielberger's State-Trait Anxiety Inventory, and the Impact of Event Scale before randomization and 1, 3, and 6 months later. Patient files provided data on utilization of psychosocial support offered in routine care. Global quality of life/health status, nausea and vomiting, and systemic therapy side effects were the subscales showing significant Group by Time interactions, favoring the interventions. Intervention groups improved statistically significantly more than the standard care group regarding insomnia, dyspnea, and financial difficulties. Nurse patients experienced less intrusion compared with the standard care group. All groups showed statistically and clinically significant improvements with time on several subscales. The intervention groups, however, improved to a greater extent. Fewer patients in the intervention groups used psychosocial hospital support compared with the standard care group. In conclusion, psychosocial support by specially trained nurses using techniques derived from cognitive behavioral therapy is beneficial for breast cancer patients and may be a realistic alternative in routine cancer care.
Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). [2020]To evaluate internet-delivered cognitive behavioural therapy (iCBT) on clinical depression and/or anxiety, distress, fear of cancer recurrence, and quality of life in cancer survivors.
Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors. [2020]This multicentre randomised controlled trial examined the efficacy of Finding My Way (FMW), a 6-week/6-module online self-guided psychotherapeutic intervention for newly diagnosed curatively treated cancer survivors, in reducing cancer-related distress and improving quality of life compared to an online attention control.
Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial. [2021]We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non-manualized supportive psycho-oncological counselling intervention (SPI).
Managing Cancer and Living Meaningfully (CALM) Intervention on Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors. [2021]Objective: To evaluate the effectiveness and feasibility of Managing Cancer and Living Meaningfully (CALM), which is used to reduce chemotherapy-related cognitive impairment (CRCI), relieve psychological distress, and improve quality of life (QOL) in Chinese breast cancer survivors (BCs). Methods: Seventy-four BCs were enrolled in this study. All patients were randomly assigned to either the CALM group or the care as usual (CAU) group. All patients were evaluated by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Distress Thermometer (DT), and the Functional Assessment of Cancer Therapy-Breast (FACT-B) before and after CALM or CAU application to BCs with CRCI. We compared the differences in all these scores between the CALM group and the control group and analyzed the correlation between cognitive function and QOL. Results: Compared with the CAU group, the performance of the CALM group on the FACT-Cog, DT, and FACT-B showed significant differences before and after CALM (t = -18.909, -5.180, -32.421, P = .000, .000, .000, respectively). Finally, there was a positive correlation between cognitive function and QOL in breast cancer patients before (r = 0.579, P = .000) and after (r = 0.797, P = .000) treatment. Conclusions: The present results indicated that CALM has salutary effects on the improvement of cognitive impairment and QOL and relieves psychological distress in breast cancer patients, which may be due to a positive correlation between psychological distress and cognitive function or QOL.
Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. [2023]To examine the effect of interventions used to enhance cognitive function in patients experiencing cancer-related cognitive impairment.
Identification of mild cognitive impairments in cancer survivors. [2013]ABSTRACT Changes in cognitive functioning are a frequent complaint of persons diagnosed and treated for cancer. The purposes of this study were to explore the feasibility of the use of the Montreal Cognitive Assessment (MoCA) for identifying mild cognitive impairment in persons who are cancer survivors as well as begin to identify the prevalence of mild cognitive impairment in cancer survivors as identified by the MoCA. Thirty-eight cancer survivors participated in this study, and 14 scored below the cutoff score of 26 on the MoCA, which indicated mild cognitive impairment. These results indicate assessment of cognitive changes in cancer patients and survivors should be part of the occupational therapy evaluation and that the MoCA is a feasible tool for such use.
Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. [2023]To examine the preliminary efficacy of Cognitive Retraining and Functional Treatment (CRAFT) combining remote computerized cognitive training (CCT) and occupation-based treatment in adults with cancer-related cognitive impairment (CRCI).
Changes and Influencing Factors of Cognitive Impairment in Patients with Breast Cancer. [2023]To investigate the changes in cognitive function and its influencing factors in patients with breast cancer after chemotherapy, to provide a scientific basis for further cognitive correction therapy.