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Completed

NCT Number: NCT02070250

Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)

Psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. These interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. One such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L. Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to train mental health professionals from across the country to deliver the BBI at their institution. Recently diagnosed cancer patients who are participating in the BBI group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). The investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. OSU will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Center of East Alabama Medical Center, Auburn, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent initial diagnosis of cancer without metastatic disease
  • Able to speak/read English

Exclusion criteria

Those with concurrent diagnoses of

  • Organic brain syndrome
  • Dementia
  • Mental retardation
  • non-English speaking
  • Significant sensory deficit
  • Severe mental illness (e.g., schizophrenia, psychotic disorder)

Treatment and study plan

From Cancer to Health (C2H-D)

Behavioral

From Cancer to Health gives people with cancer the information and tools they need to manage their stress to improve their health throughout the cancer journey. Each institution involved in this study will implement the core techniques of the C2H-D Intervention but may alter the format somewhat to meet their patient population needs (e.g., shorten hourly 18 week intervention into 2-hour 9 week intervention).

Other names: C2H, Biobehavioral Intervention, BBI, Stress management

Primary outcomes

  1. Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

  2. Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

Secondary outcomes

  1. Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

  2. Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

  3. Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

  4. Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

Other outcomes

  1. Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

  2. Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

  3. Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, up to 18 weeks

    The intensive intervention length can vary by location from 4 to 18 weeks.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals

Acronym: C2H-D

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2014
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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