Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia

Danish Cancer Society

Status: Completed

Conditions: Cancer of Prostate; Insomnia

Treatments: Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03444532

Sleep-Now

Details and patient eligibility

About

This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.

Full description

This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.

In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate cancer
• Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
• Insomnia
• Over 18-yers old
• Understand oral and written Danish
• Written informed consent

Exclusion criteria

• Medical assessment that does not allow aerobic exercise
• Severe cognitive problems
• Night work during the interventions period
• Exercise training more than three times a week

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

12-week aerobic exercise and cognitive-behavioral therapy

Experimental group

Description:

12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions

Treatment:

Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy

Control group

No Intervention group

Description:

Patients assigned to the control group will receive usual care