CancerNCT01061801
Spouses/Partners Expressing Their Thoughts After Transplant
A study testing Emotional expression in people with Cancer and Hematopoietic Stem Cell Transplantation, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This study seeks to test a brief psychological intervention for spousal caregivers of cancer patients (specifically, hematopoietic stem cell transplant patients), persons known to experience emotional distress. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Emotional expression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2009
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients and partners at least 21 years of age
- patients and partners English speaking
- patients about to receive a hematopoietic stem cell transplant
- patients married or in a committed, cohabiting, heterosexual or homosexual relationship
- caregivers in a married or committed, cohabiting, heterosexual or homosexual relationship with the patient
- caregivers present at the transplant site and planning to remain so for at least one month
Who cannot join
- patient major psychiatric disorder
- caregiver presence or history of a neurologic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Emotional Expression and Cancer Caregivers
This study seeks to test a brief psychological intervention for spousal caregivers of cancer patients (specifically, hematopoietic stem cell transplant patients), persons known to experience emotional distress.
Read the detailed description
This project focuses on spousal caregivers (CGs) of hematopoietic stem cell transplant survivors - persons known to report elevated levels of distress as compared to both norms and their patient counterparts. Specific Aims are to: (1) Determine, via experimental manipulation, whether or not CGs of hematopoietic stem cell transplant patients engage in protective buffering, a coping mechanism whereby partners shield patients from illness-related concerns or worries, (2) Examine synchrony or lack thereof, desynchrony, among subjective, expressive and biologic indicators of emotion among spousal CGs, and (3) Test the feasibility and implementation of an emotional expression (EE) exercise designed to enhance psychological and immune functioning among spousal CGs.
- Conditions
- Cancer, Hematopoietic Stem Cell Transplantation
- Being tested
- Emotional expression
- Keywords
- caregivers, cancer, emotion, protective buffering
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional expressionBehavioural
Also called Emotional disclosure
Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver
| Study group | Role | What they receive |
|---|---|---|
| Emotional expression, patient present | Experimental | Caregivers are asked to talk about their deepest thoughts and feelings regarding the patient's transplant and their role as caregiver, in the presence of the patient (one session). Receives: Behavioral: Emotional expression |
| Emotional expression, patient absent | Experimental | Caregivers are asked to talk about their deepest thoughts and feelings regarding the patient's transplant and their role as caregiver, in the absence of the patient (3 sessions). Receives: Behavioral: Emotional expression |
| Comparison | Active comparator | Caregivers are asked to talk about their plans for the upcoming week (time management, sessions 1 and 3) and positive aspects of their life (session 2). Receives: Behavioral: Emotional expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported mental and physical health as measured by the Short Form-36 Health Survey
Measured: baseline, 1-month follow-up, and 4-month follow-up
Marital satisfaction as measured by the Dyadic Adjustment Scale
Measured: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up
Self- and partner-reported protective buffering as measured by the Protective Buffering Scale
Measured: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up
Secondary outcomes (3)
Emotional experience as assessed by the Positive and Negative Affect Schedule
Measured: During intervention/ disclosure sessions
Galvanic skin response (physiological indicator of emotion)
Measured: During intervention/ disclosure sessions
Emotional expression (facial expression and words uttered)
Measured: During intervention/ disclosure sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Investigators
- Shelby Langer, PhD, Principal investigator, FHCRC/UW Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061801
- Sponsor's protocol ID
- 2076.00
- Status last verified
- Feb 2010
- First submitted
- 2 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Langer SL, Brown JD, Syrjala KL. Intrapersonal and interpersonal consequences of protective buffering among cancer patients and caregivers. Cancer. 2009 Sep 15;115(18 Suppl):4311-25. doi: 10.1002/cncr.24586.
PubMed 19731352
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Expression and Cancer Caregivers
- ClinicalTrials.gov ID
- NCT01061801
- Acronym / sponsor ID
- 2076.00
- Conditions
- Cancer, Hematopoietic Stem Cell Transplantation
- Keywords
- caregivers, cancer, emotion, protective buffering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Feb 2010 (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 study seeks to test a brief psychological intervention for spousal caregivers of cancer patients (specifically, hematopoietic stem cell transplant patients), persons known to experience emotional distress.
Detailed description
This project focuses on spousal caregivers (CGs) of hematopoietic stem cell transplant survivors - persons known to report elevated levels of distress as compared to both norms and their patient counterparts. Specific Aims are to: (1) Determine, via experimental manipulation, whether or not CGs of hematopoietic stem cell transplant patients engage in protective buffering, a coping mechanism whereby partners shield patients from illness-related concerns or worries, (2) Examine synchrony or lack thereof, desynchrony, among subjective, expressive and biologic indicators of emotion among spousal CGs, and (3) Test the feasibility and implementation of an emotional expression (EE) exercise designed to enhance psychological and immune functioning among spousal CGs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emotional expression, patient present | Experimental | Behavioral: Emotional expressionCaregivers are asked to talk about their deepest thoughts and feelings regarding the patient's transplant and their role as caregiver, in the presence of the patient (one session). |
| Emotional expression, patient absent | Experimental | Behavioral: Emotional expressionCaregivers are asked to talk about their deepest thoughts and feelings regarding the patient's transplant and their role as caregiver, in the absence of the patient (3 sessions). |
| Comparison | Active comparator | Behavioral: Emotional expressionCaregivers are asked to talk about their plans for the upcoming week (time management, sessions 1 and 3) and positive aspects of their life (session 2). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients and partners at least 21 years of age
- patients and partners English speaking
- patients about to receive a hematopoietic stem cell transplant
- patients married or in a committed, cohabiting, heterosexual or homosexual relationship
- caregivers in a married or committed, cohabiting, heterosexual or homosexual relationship with the patient
Key exclusion criteria (2 listed)
- patient major psychiatric disorder
- caregiver presence or history of a neurologic disorder
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 |
|---|---|---|
| Emotional expressionAlso: Emotional disclosureCaregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver | Behavioural | Comparison, Emotional expression, patient absent, Emotional expression, patient present |
Primary outcome
Self-reported mental and physical health as measured by the Short Form-36 Health Survey
Time frame: baseline, 1-month follow-up, and 4-month follow-up
Marital satisfaction as measured by the Dyadic Adjustment Scale
Time frame: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up
Self- and partner-reported protective buffering as measured by the Protective Buffering Scale
Time frame: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up
3 secondary outcomes
Emotional experience as assessed by the Positive and Negative Affect Schedule
Time frame: During intervention/ disclosure sessions
Galvanic skin response (physiological indicator of emotion)
Time frame: During intervention/ disclosure sessions
Emotional expression (facial expression and words uttered)
Time frame: During intervention/ disclosure sessions
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 8 Feb 2010.
- Results publication: PubMed 19731352Langer SL, Brown JD, Syrjala KL. Intrapersonal and interpersonal consequences of protective buffering among cancer patients and caregivers. Cancer. 2009 Sep 15;115(18 Suppl):4311-25. doi: 10.1002/cncr.24586.
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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.
Shelby Langer, PhD principal investigator
FHCRC/UW Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional expression in people with Cancer and Hematopoietic Stem Cell Transplantation, run by Fred Hutchinson Cancer Center at 1 site 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 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Self-reported mental and physical health as measured by the Short Form-36 Health Survey (time frame: baseline, 1-month follow-up, and 4-month follow-up). The study lists 3 primary outcomes in all. 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 NCT01061801, which also lists 1 linked publication.
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 8 Feb 2010.