Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial

NCT ID: NCT02288169

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-07-31

Brief Summary

Regardless of their treatment, cancer patients endure a variety of difficult symptoms during their disease with averages ranging from 7 to 14 symptoms each. Cancer-related symptoms, especially when symptoms are very intense, distressing, frequent, or interfere with daily activities, can lead to depression, anxiety, and diminished quality of life. Improving their ability to self-manage difficult symptoms has the potential to diminish suffering, improve quality of life and decrease emergency room visits and associated costs. The investigators propose to test a brief, effective intervention with outpatients in a cancer center, with the goal of teaching patients symptom management skills for self-identified symptoms of highest priority to patients. Objective: The proposed randomized clinical trial will test the efficacy of the COPE intervention with patients with symptoms of moderate to high intensity, distress, frequency or interference with their lives as a result of their cancer. Method: The investigators will seek 300 completed subjects, outpatients with breast, colorectal, lung, and prostate cancers. Patients will be randomized into three groups. Group III, the experimental group, will receive usual care plus the COPE intervention. This group will receive 3 individual intervention sessions. During the first intervention visit at the cancer center, the COPE group will be taught the COPE intervention in a session focusing on the patient's self-identified most bothersome symptom. Role modeling and additional instruction will be provided via video, and patients will receive the Home Care Guide for Cancer and a copy of the video to take home. Three subsequent visits with the patient during regularly scheduled clinic visits will reinforce the principles of COPE and the use of the Home Care Guide, and will help patients apply this approach to managing other symptoms. In addition they will get 2 phone calls encouraging them to apply COPE. Group II, the attention control group, will receive supportive visits from the research team at the cancer center and subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls, matched for time with COPE participants. Group I, the control group receiving usual care, will receive no additional attention from our interventionists. Data will be collected weekly for 9 weeks about symptoms (intensity, frequency, interference, appraisal of distress), self-efficacy, and barriers to self-management. Patient Outcomes: Quality of life, anxiety and depression will be assessed at baseline and weeks 4, 8, and 12. The investigators predict that the COPE group will show significant improvement in depression, anxiety, quality of life, symptom intensity, distress, frequency and interference, self-efficacy, and perceived barriers to care, as well as decreased utilization of health care resources compared with the two control groups. Data will be analyzed using repeated measures multivariate analysis of variance using a mixed model approach.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

COPE

The experimental group will receive usual care plus the COPE intervention. This group will receive 3 individual intervention sessions. During the first intervention visit at the cancer center, the COPE group will be taught the COPE intervention in a session focusing on the patient's self-identified most bothersome symptom. Role modeling and additional instruction will be provided via video, and patients will receive the Home Care Guide for Cancer and a copy of the video to take home. Three subsequent visits with the patient during regularly scheduled clinic visits will reinforce the principles of COPE and the use of the Home Care Guide, and will help patients apply this approach to managing other symptoms. In addition they will get 2 phone calls encouraging them to apply COPE.

Group Type: EXPERIMENTAL

COPE

Intervention Type: BEHAVIORAL

We propose to test a brief, effective intervention with outpatients in a cancer center, with the goal of teaching patients symptom management skills for self-identified symptoms of highest priority to patients. The proposed randomized clinical trial will test the efficacy of the COPE intervention with patients with symptoms of moderate to high intensity, distress, frequency or interference with their lives as a result of their cancer.

Support

The attention control group will receive supportive visits from the research team at the cancer center and subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls, matched for time with COPE participants.

Group Type: SHAM_COMPARATOR

Support/Attention Control

Intervention Type: BEHAVIORAL

The attention control group will receive supportive visits from the research team at the cancer center and subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls

Control

The control group will receive usual care and no additional attention from our interventionists.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

COPE

We propose to test a brief, effective intervention with outpatients in a cancer center, with the goal of teaching patients symptom management skills for self-identified symptoms of highest priority to patients. The proposed randomized clinical trial will test the efficacy of the COPE intervention with patients with symptoms of moderate to high intensity, distress, frequency or interference with their lives as a result of their cancer.

Intervention Type: BEHAVIORAL

Support/Attention Control

The attention control group will receive supportive visits from the research team at the cancer center and subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Breast, colorectal, lung or prostate cancer patients with baseline scores on intensity, distress, and/or interference => 4 on at least 2 symptoms
• Literate in English
• Must pass mental status screening and functional status at the level of ECOG 3 or lower

Exclusion Criteria

• patients who plan to leave Florida during the summer,
• are in hospice care, or
• confused, or
• expected to die within 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

USflorida

Identifier Type: -

Identifier Source: org_study_id