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Completed

NCT Number: NCT00709176

Outcomes of Triaged Family Care in Advanced Cancer

The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.

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Key information

Conditions

Advanced Cancer Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Communication Depression Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States

Loading trial locations.

About this study

The purpose of this study is to:

  • determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care
  • determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low).

A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
  • Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
  • For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
  • Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.

Exclusion criteria

  • Patients will be excluded if they have multiple primary cancer sites.
  • Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.

Treatment and study plan

Brief FOCUS Program

Behavioral

Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.

Other names: Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S), Family-based Intervention, Cancer Patient and Family Member Intervention

Extensive FOCUS Program

Behavioral

Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.

Other names: Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S), Family-based Intervention, Cancer Patient and Family Member Intervention

Primary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 3 and 6 months

Secondary outcomes

  1. Risk for Distress

    Time frame: Baseline

  2. Change in Emotional Distress

    Time frame: Baseline, 3 and 6 months

  3. Change in Appraisal of Illness/Caregiving

    Time frame: Baseline, 3 and 6 months

  4. Change in Uncertainty

    Time frame: Baseline, 3 and 6 months

  5. Change in Hopelessness

    Time frame: Baseline, 3 and 6 months

  6. Change in Self-efficacy

    Time frame: Baseline, 3 and 6 months

  7. Change in Benefits of Illness

    Time frame: Baseline, 3 and 6 months

  8. Change in Family Communication

    Time frame: Baseline, 3 and 6 months

  9. Change in Support

    Time frame: Baseline, 3 and 6 months

  10. Change in Depression

    Time frame: Baseline, 3 and 6 months

  11. Change in Coping

    Time frame: Baseline, 3 and 6 months

  12. Change in Health Care Resource Utilization

    Time frame: Baseline, 3 and 6 months

  13. Change in Caregiver Burden

    Time frame: Baseline, 3 and 6 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Cancer Institute (NCI)
  • Wayne State University

Registry information

Acronym: FOCUS-Triage

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 3, 2008
Registry last updated
Feb 11, 2014

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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