Breast CancerNCT02129049
Telephone-Based Educational Intervention in Improving Communication Between Patients With Stage 0-III Cancer and Their Children
A study testing educational intervention, telephone-based intervention and questionnaire administration in people with Breast Cancer and Cervical Cancer, run by University of Washington at 11 sites in United States.
Trial summary
This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Colon Cancer
- What is being tested?
- educational intervention, telephone-based intervention and questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2014to Jul 2015
- 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
- Parents will be eligible if they have an initial diagnosis of non-metastatic cancer of any type (stage 0-3), including melanoma, colorectal, cervical, leukemia, lymphoma or breast cancer within the past 7 months
- Read and write English among their languages of choice
- Have ready access to a telephone
- Have a child 5-12 years old living at home who has been told their parent's cancer diagnosis
- The child is living at home and does not have learning challenges
- No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, 99336
Tri-Cities Cancer Center
Kennewick, Washington, 99336
SCCA at EvergreenHealth
Kirkland, Washington, 98033
Skagit Valley Hospital
Mount Vernon, Washington, 98274
Olympic Medical Center
Port Angeles, Washington, 98362
Group Health Cooperative
Redmond, Washington, 98052
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
Swedish Cancer Institute
Seattle, Washington, 98122-4307
Multicare Health System
Tacoma, Washington, 98415
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801
About this study
Official title: Enhancing Connections Telephone Program: A Cancer Education Program for Parents
This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the feasibility of the recruitment and study protocol.
II. Evaluate the short-term impact of the program on the diagnosed parents' and the parent's perceptions of their children's adjustment using a within group design (pre-posttest design).
III. To compare outcomes from the telephone-delivered program with outcomes obtained from the in-person program (between group design).
OUTLINE:
Participants complete the Enhancing Connections Telephone Program comprising 5, 1 hour educational telephone sessions over 3 months. During session 1, parents receive help defining the child's experience with the cancer as distinct from their own and ways to manage their own cancer-related emotions so that they do not emotionally flood the child. During session 2, parents receive assistance with developing skills to deeply listen and attend to the child's thoughts and feelings, complementing the parent's tendency to be a teacher, not a deep listener, of the child's thoughts, concerns, worries or understandings. During session 3, parents receive additional communication and parenting skills enabling them to initiate difficult cancer-related conversations and also interact with an upset child or one who is not forthcoming. During session 4, parents receive help focusing on and non-judgmentally interpreting the child's ways of coping with the cancer. It includes exercises that assist the parent to relinquish negative assumptions about the child's behavior related to the parent's cancer. Concurrently the session offers the ill parent ways to elicit their child's report of what the parent can do to assist the child cope with the child's cancer-related pressures. During session 5, parents focus on the gains they made in prior sessions and what they have accomplished, in their own words, in parenting their child about the cancer. The session also assists the ill parent to identify available resources that can be used after program completion to maintain the parent's newly acquired gains from the program.
- Conditions
- Breast Cancer, Cervical Cancer, Colon Cancer, Leukemia, Lymphoma, Malignant Neoplasm
- Being tested
- educational intervention, telephone-based intervention, questionnaire administration
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colonic Neoplasms, Leukemia, Lymphoma, Neoplasms, Melanoma, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Participate in the Enhancing Connections Telephone Program
telephone-based interventionBehavioural
Participate in the Enhancing Connections Telephone Program
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Enhancing Connections Telephone Program) | Experimental | See Detailed Description. Receives: Other: educational intervention; Behavioral: telephone-based intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention, monitored by tracking detailed recruitment spreadsheets
Each referral source and method of referral will be monitored, including documenting reason for refusal. Four methods of recruitment will be monitored in order to know which method yields the highest enrollment: self-referral, provider referral, passive letter opt-in, and passive letter opt-out.
Measured: Up to 3 months
Dosage and fidelity, monitored for each intervention session using Performance Checklists
Each audio-recorded intervention session will be reviewed against these checklists. Study participants' compliance with the in-session and at-home assignments will be monitored by the audio-recorded intervention sessions.
Measured: Up to 3 months
Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale
Measured: Up to 3 months
Rate of receipt of mailed materials both to participants and from participants
Materials include signed consents, baseline data, and parent's educational materials.
Measured: Up to 3 months
Duration of phone intervention sessions
Measured: Up to 3 months
Rate of success in scheduling and completing intervention sessions by telephone
Measured: Up to 3 months
Quality of data on baseline and post-intervention measures
Measured: Up to 3 months
Short-term impact of the program, evaluated by comparing the change in pre- and post-test scores on the standardized questionnaires
Analysis of covariance (ANCOVA) will be used to test for significant differences between pre- and post-test scores, assuming the data meet the statistical assumptions. Baseline scores will serve as the covariate, along with empirical variables that are known to co-vary with parent and child functioning, e.g., length of time of diagnosis, type of medical treatment, adjuvant therapy, among others). Two-tailed tests of significance will be calculated, allowing us to evaluate any potential negative effects of the intervention.
Measured: Baseline up to 3 months
Impact of the telephone-delivered compared to the in-person delivered program
Linear mixed modeling will be used. Random effects models are based on Maximum Likelihood Estimation in which an iterative method estimates a trajectory for each study participant based on all available data for that participant supplemented by data obtained from the total sample.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frances Lewis, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129049
- Sponsor's protocol ID
- 9095
- Other IDs
- NCI-2014-00928, 9095, R03CA178488, P30CA015704
- Status last verified
- Mar 2016
- First submitted
- 30 Apr 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Connections Telephone Program: A Cancer Education Program for Parents
- ClinicalTrials.gov ID
- NCT02129049
- Acronym / sponsor ID
- 9095
- Conditions
- Breast Cancer, Cervical Cancer, Colon Cancer, Leukemia, Lymphoma, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- First posted
- 2 May 2014 (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.
This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer.
Detailed description
PRIMARY OBJECTIVES:
- Test the feasibility of the recruitment and study protocol.
II. Evaluate the short-term impact of the program on the diagnosed parents' and the parent's perceptions of their children's adjustment using a within group design (pre-posttest design).
III. To compare outcomes from the telephone-delivered program with outcomes obtained from the in-person program (between group design).
OUTLINE:
Participants complete the Enhancing Connections Telephone Program comprising 5, 1 hour educational telephone sessions over 3 months. During session 1, parents receive help defining the child's experience with the cancer as distinct from their own and ways to manage their own cancer-related emotions so that they do not emotionally flood the child. During session 2, parents receive assistance with developing skills to deeply listen and attend to the child's thoughts and feelings, complementing the parent's tendency to be a teacher, not a deep listener, of the child's thoughts, concerns, worries or understandings. During session 3, parents receive additional communication and parenting skills enabling them to initiate difficult cancer-related conversations and also interact with an upset child or one who is not forthcoming. During session 4, parents receive help focusing on and non-judgmentally interpreting the child's ways of coping with the cancer. It includes exercises that assist the parent to relinquish negative assumptions about the child's behavior related to the parent's cancer. Concurrently the session offers the ill parent ways to elicit their child's report of what the parent can do to assist the child cope with the child's cancer-related pressures. During session 5, parents focus on the gains they made in prior sessions and what they have accomplished, in their own words, in parenting their child about the cancer. The session also assists the ill parent to identify available resources that can be used after program completion to maintain the parent's newly acquired gains from the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Enhancing Connections Telephone Program) | Experimental | Other: educational intervention, Behavioral: telephone-based intervention, Other: questionnaire administrationSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Parents will be eligible if they have an initial diagnosis of non-metastatic cancer of any type (stage 0-3), including melanoma, colorectal, cervical, leukemia, lymphoma or breast cancer within the past 7 months
- Read and write English among their languages of choice
- Have ready access to a telephone
- Have a child 5-12 years old living at home who has been told their parent's cancer diagnosis
- The child is living at home and does not have learning challenges
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalParticipate in the Enhancing Connections Telephone Program | Other | Supportive care (Enhancing Connections Telephone Program) |
| telephone-based interventionParticipate in the Enhancing Connections Telephone Program | Behavioural | Supportive care (Enhancing Connections Telephone Program) |
| questionnaire administrationAncillary studies | Other | Supportive care (Enhancing Connections Telephone Program) |
Primary outcome
Recruitment and retention, monitored by tracking detailed recruitment spreadsheets
Time frame: Up to 3 months
Each referral source and method of referral will be monitored, including documenting reason for refusal. Four methods of recruitment will be monitored in order to know which method yields the highest enrollment: self-referral, provider referral, passive letter opt-in, and passive letter opt-out.
Dosage and fidelity, monitored for each intervention session using Performance Checklists
Time frame: Up to 3 months
Each audio-recorded intervention session will be reviewed against these checklists. Study participants' compliance with the in-session and at-home assignments will be monitored by the audio-recorded intervention sessions.
Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale
Time frame: Up to 3 months
Rate of receipt of mailed materials both to participants and from participants
Time frame: Up to 3 months
Materials include signed consents, baseline data, and parent's educational materials.
Duration of phone intervention sessions
Time frame: Up to 3 months
Rate of success in scheduling and completing intervention sessions by telephone
Time frame: Up to 3 months
Quality of data on baseline and post-intervention measures
Time frame: Up to 3 months
Short-term impact of the program, evaluated by comparing the change in pre- and post-test scores on the standardized questionnaires
Time frame: Baseline up to 3 months
Analysis of covariance (ANCOVA) will be used to test for significant differences between pre- and post-test scores, assuming the data meet the statistical assumptions. Baseline scores will serve as the covariate, along with empirical variables that are known to co-vary with parent and child functioning, e.g., length of time of diagnosis, type of medical treatment, adjuvant therapy, among others). Two-tailed tests of significance will be calculated, allowing us to evaluate any potential negative effects of the intervention.
Impact of the telephone-delivered compared to the in-person delivered program
Time frame: Up to 3 months
Linear mixed modeling will be used. Random effects models are based on Maximum Likelihood Estimation in which an iterative method estimates a trajectory for each study participant based on all available data for that participant supplemented by data obtained from the total sample.
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 9 Mar 2016.
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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.
Frances Lewis principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, telephone-based intervention and questionnaire administration in people with Breast Cancer and Cervical Cancer, run by University of Washington at 11 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 6 inclusion and 0 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Recruitment and retention, monitored by tracking detailed recruitment spreadsheets (time frame: Up to 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2016.