Advanced CancerFOCUS-TriageNCT00709176
Outcomes of Triaged Family Care in Advanced Cancer
A study testing Brief FOCUS Program and Extensive FOCUS Program in people with Advanced Cancer, run by University of Michigan at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Brief FOCUS Program and Extensive FOCUS Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2005to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Karmanos Cancer Center
Detroit, Michigan, 48202
Wayne State University
Detroit, Michigan, 48202
Providence Hospital Cancer Institute
Southfield, Michigan, 48075
About this study
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.
Read the detailed description
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.
- Conditions
- Advanced Cancer
- Being tested
- Brief FOCUS Program, Extensive FOCUS Program
- Keywords
- Quality of Life, Randomized Clinical Trial, Advanced Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Family caregiver, cancer survivorship, coping, communication, uncertainty, support, depression, self-efficacy, benefits of illness, Caregivers
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Communication, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief FOCUS ProgramBehavioural
Also called Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S), Family-based Intervention, Cancer Patient and Family Member Intervention
Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.
Extensive FOCUS ProgramBehavioural
Also called Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S), Family-based Intervention, Cancer Patient and Family Member Intervention
Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.
| Study group | Role | What they receive |
|---|---|---|
| Brief | Experimental | Dyads randomized to BRIEF arm received the Brief FOCUS Program (two home visits and one phone call by a trained nurse) in addition to standard clinical care. Receives: Behavioral: Brief FOCUS Program |
| Extensive | Experimental | Dyads randomized to EXTENSIVE arm received the Extensive FOCUS Program (4 home visits and two phone calls by a trained nurse) in addition to standard clinical care. Receives: Behavioral: Extensive FOCUS Program |
| Control | No intervention | Dyads randomized to CONTROL arm continued with standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Measured: Baseline, 3 and 6 months
Secondary outcomes (13)
Risk for Distress
Measured: Baseline
Change in Emotional Distress
Measured: Baseline, 3 and 6 months
Change in Appraisal of Illness/Caregiving
Measured: Baseline, 3 and 6 months
Change in Uncertainty
Measured: Baseline, 3 and 6 months
Change in Hopelessness
Measured: Baseline, 3 and 6 months
Change in Self-efficacy
Measured: Baseline, 3 and 6 months
Change in Benefits of Illness
Measured: Baseline, 3 and 6 months
Change in Family Communication
Measured: Baseline, 3 and 6 months
Change in Support
Measured: Baseline, 3 and 6 months
Change in Depression
Measured: Baseline, 3 and 6 months
Change in Coping
Measured: Baseline, 3 and 6 months
Change in Health Care Resource Utilization
Measured: Baseline, 3 and 6 months
Change in Caregiver Burden
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University, National Cancer Institute (NCI)
- Investigators
- Laurel L Northouse, PhD, RN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709176
- Sponsor's protocol ID
- R01CA107383
- Other IDs
- R01CA107383, UMCC 2003-094, IRBMED No. 2004-0129
- Acronym
- FOCUS-Triage
- Status last verified
- Oct 2013
- First submitted
- 1 Jul 2008
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Northouse L. Helping families of patients with cancer. Oncol Nurs Forum. 2005 Jul 1;32(4):743-50. doi: 10.1188/05.onf.743-750.
PubMed 15990903Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, LoRusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31.
PubMed 22290823Guan T, Chapman MV, de Saxe Zerden L, Zimmer C, Braden CJ, Rizo CF, Northouse L, Song L. Illness uncertainty and quality of life in patients with advanced cancer and their family caregivers: An actor-partner interdependence model analysis. Psychooncology. 2023 Nov;32(11):1744-1751. doi: 10.1002/pon.6228. Epub 2023 Oct 4.
PubMed 37794604
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Triaged Family Care in Advanced Cancer
- ClinicalTrials.gov ID
- NCT00709176
- Acronym / sponsor ID
- FOCUS-Triage / R01CA107383
- Conditions
- Advanced Cancer
- Keywords
- Quality of Life, Randomized Clinical Trial, Advanced Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Family caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Wayne State University, National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief | Experimental | Behavioral: Brief FOCUS ProgramDyads randomized to BRIEF arm received the Brief FOCUS Program (two home visits and one phone call by a trained nurse) in addition to standard clinical care. |
| Extensive | Experimental | Behavioral: Extensive FOCUS ProgramDyads randomized to EXTENSIVE arm received the Extensive FOCUS Program (4 home visits and two phone calls by a trained nurse) in addition to standard clinical care. |
| Control | No intervention | –Dyads randomized to CONTROL arm continued with standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief FOCUS ProgramAlso: Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S), Family-based Intervention, Cancer Patient and Family Member InterventionDyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse. | Behavioural | Brief |
| Extensive FOCUS ProgramAlso: Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S), Family-based Intervention, Cancer Patient and Family Member InterventionDyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse. | Behavioural | Extensive |
Primary outcome
Change in Quality of Life
Time frame: Baseline, 3 and 6 months
13 secondary outcomes
Risk for Distress
Time frame: Baseline
Change in Emotional Distress
Time frame: Baseline, 3 and 6 months
Change in Appraisal of Illness/Caregiving
Time frame: Baseline, 3 and 6 months
Change in Uncertainty
Time frame: Baseline, 3 and 6 months
Change in Hopelessness
Time frame: Baseline, 3 and 6 months
Change in Self-efficacy
Time frame: Baseline, 3 and 6 months
Change in Benefits of Illness
Time frame: Baseline, 3 and 6 months
Change in Family Communication
Time frame: Baseline, 3 and 6 months
Change in Support
Time frame: Baseline, 3 and 6 months
Change in Depression
Time frame: Baseline, 3 and 6 months
Change in Coping
Time frame: Baseline, 3 and 6 months
Change in Health Care Resource Utilization
Time frame: Baseline, 3 and 6 months
Change in Caregiver Burden
Time frame: Baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Background: PubMed 15990903Northouse L. Helping families of patients with cancer. Oncol Nurs Forum. 2005 Jul 1;32(4):743-50. doi: 10.1188/05.onf.743-750.
- Results publication: PubMed 22290823Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, LoRusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31.
- Derived from this study: PubMed 37794604Guan T, Chapman MV, de Saxe Zerden L, Zimmer C, Braden CJ, Rizo CF, Northouse L, Song L. Illness uncertainty and quality of life in patients with advanced cancer and their family caregivers: An actor-partner interdependence model analysis. Psychooncology. 2023 Nov;32(11):1744-1751. doi: 10.1002/pon.6228. Epub 2023 Oct 4.
- University of Michigan Comprehensive Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurel L Northouse, PhD, RN principal investigator
University of Michigan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief FOCUS Program and Extensive FOCUS Program in people with Advanced Cancer, run by University of Michigan at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709176, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.