NCT01415089

Brief Summary

The purpose of this pilot study is to develop a personalized, interactive, and web-based module for cancer patients and a family caregiver. The three-session module will be designed to help patients and family caregivers improve their communication and support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started May 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

June 16, 2015

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

August 10, 2011

Last Update Submit

June 15, 2015

Conditions

Breast CancerColorectal CancerLung CancerProstate Cancer

Keywords

CancerQuality of lifeFamily caregiverStress and copingWeb-based interventionCommunication

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of quality of life (FACT-G Scale) will be conducted.

    Baseline (Time 1) and 2 months (Time 2)

Secondary Outcomes (6)

  • Communication

    Baseline (Time 1) and 2 months (Time 2)

  • Dyadic support

    Baseline (Time 1) and 2 months (Time 2)

  • Self-efficacy

    Baseline (Time 1) and 2 months (Time 2)

  • Perceived benefits of illness

    Baseline (Time 1) and 2 months (Time 2)

  • Emotional distress

    Baseline (Time 1) and 2 months (Time 2)

  • +1 more secondary outcomes

Interventions

FOCUS-WebBEHAVIORAL

A 3-session individually tailored, interactive, web-based program providing support and education for cancer patients and one of their family caregivers.

Also known as: FOCUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cancer patients with confirmed diagnosis of breast, colorectal, lung or prostate cancer
  • early stage (I or II, diagnosed within past 2 to 12 months) OR advanced stage (III or IV, diagnosed or progressed within past 2 to 12 months)
  • age 18 or older
  • physically/mentally able to participate
  • speak/read/write English
  • have access to internet at home
  • have a family caregiver willing to participate
  • family caregivers must be age 18 or older, physically/mentally able to participate, able to speak/read/write English, identified by the patient as his or her primarily family caregiver, and have access to and willing to use the internet. "Family caregiver" is defined as the family member or significant other identified by the patient as his or her primary source of emotional or physical support during the current cancer experience and confirmed by the designated individual.

You may not qualify if:

  • Family caregivers will be excluded from the study if they themselves have been diagnosed with cancer in the previous year or are receiving active treatment for cancer. This criteria was established so all dyads are managing effects of cancer in patients, not the family caregivers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

  • Zulman DM, Schafenacker A, Barr KL, Moore IT, Fisher J, McCurdy K, Derry HA, Saunders EW, An LC, Northouse L. Adapting an in-person patient-caregiver communication intervention to a tailored web-based format. Psychooncology. 2012 Mar;21(3):336-41. doi: 10.1002/pon.1900. Epub 2011 Jan 23.

    PMID: 21830255BACKGROUND

  • Northouse L, Schafenacker A, Barr KL, Katapodi M, Yoon H, Brittain K, Song L, Ronis DL, An L. A tailored Web-based psychoeducational intervention for cancer patients and their family caregivers. Cancer Nurs. 2014 Sep-Oct;37(5):321-30. doi: 10.1097/NCC.0000000000000159.

    PMID: 24945270RESULT

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsLung NeoplasmsProstatic NeoplasmsNeoplasmsCommunication

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Laurel Northouse, PhD

    University of Michigan School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 16, 2015

Record last verified: 2013-10

Locations

US(3)