Kidney CancerNCT00505310
Biobehavioral Effects of Emotional Expression in Cancer
A study testing Writing and Questionnaire in people with Kidney Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The proposed study will assess the psychological and physiological benefits of an emotional expression intervention in patients with renal cancer. Patients will be randomly assigned to an emotional expression writing group or to a neutral writing group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Writing and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2002to 10 Aug 2022
- 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
- 1) Men or woman older than 18 years with stage I-IV renal cell carcinoma 2) Zubrod performance status of less than or equal to 2 3) have no serious intercurrent medical illness 4) read and speak English
Who cannot join
- 1) Score of 23 or below on the Mini-mental 2) History of primary or secondary immunodeficiency 3) Taking immunosuppressive drugs such as systemic corticosteroid 4) Patients who are undergoing a surgical procedure and do not sign the general tissue consent form 5) Patients with major psychiatric diagnoses or currently seeking psychological counseling.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The proposed study will assess the psychological and physiological benefits of an emotional expression intervention in patients with renal cancer. Patients will be randomly assigned to an emotional expression writing group or to a neutral writing group. This study will also evaluate the extent to which psychosocial factors mediate the intervention program and predict patients' recovery and adjustment to treatment. Potential mediators include level of cognitive processing, social networks/interactions, and sense of coherence and ability to find meaning in the illness experience.
Specific objectives of the proposed research are:
- To evaluate an emotional expression intervention in patients with renal cancer. Researchers will determine the extent to which an emotional expression writing-based intervention enhances adjustment during the first 12 months following diagnosis and treatment. Dimensions of adjustment will be assessed by examining indices of QOL, mental health, and stress (subjective symptoms of distress, perceived stress, and mood).
- To determine the effects of an emotional expression writing-based intervention on immune function. The immune measures assessed in this study will include both general and autologous tumor-specific immune responses including cytotoxicity to K562 target cells; cytotoxicity to autologous tumor target cells; and functional assessment of type-1 and type-2 cytokines using autologous tumor and polyclonal stimulants.
- To identify the psychosocial processes underlying the efficacy of the intervention.
Read the detailed description
Patients in this study will already be scheduled for surgery/ablation, or for chemotherapy and/or radiation treatment. Patients undergoing surgery/ablation will complete some questionnaires about their mood and quality of life. These questionnaires will happen about 6 weeks after their procedure, during their scheduled visit to M.D. Anderson to follow-up after their surgery. Patients scheduled to receive chemotherapy and/or radiation treatment will complete the same questionnaires around the time of their new patient consult visit at M.D. Anderson. They should take about 60 minutes to complete. About 8 teaspoons of blood will be drawn to measure immune function.
Patients will then be randomly picked (as in the toss of a coin) to be in one of two groups. One group will be the emotional expression writing group. The other group will be the neutral writing group.
Patients in both groups will be asked to write for 20 minutes on different topics at four different times. They will be asked to complete all assignments in their home. They will choose four separate times when they would like to do the writing assignments and a research assistant will prompt them with a phone call at those times. During these phone calls, patients will complete a brief mood evaluation before the start of the writing session. After 20 minutes, patients will receive another phone call to signal that they should stop writing. A second mood assessment will also be given at this time. Patients will be provided with a pre-addressed, stamped envelope for mailing each writing sample back to M. D. Anderson the day after it is completed.
Patients will complete some questionnaires about their mood and quality of life approximately 1 month, 4 months, and 10 months after their last writing assignment. They should take about 60 minutes to complete. About 8 teaspoons of blood will then be taken each time to measure immune function.
This is an investigational study. As many as 710 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Kidney Cancer
- Being tested
- Writing, Questionnaire
- Keywords
- Kidney Cancer, Renal Cell Carcinoma, Emotional Expression, Writing, Questionnaire, Survey
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WritingBehavioural
20 minutes of writing on different topics at four different times.
QuestionnaireBehavioural
Also called Survey
Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Expression Writing | Experimental | 20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment. Receives: Behavioral: Writing; Behavioral: Questionnaire |
| Neutral Writing | Experimental | 20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment. Receives: Behavioral: Writing; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer.
Measured: 8 Years
Secondary outcomes (1)
To learn how the expression of emotions affects quality of life, stress, and immune function.
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study start21 Aug 2002
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505310
- Sponsor's protocol ID
- ID00-168
- Other IDs
- NCI-2012-02100
- Status last verified
- Aug 2022
- First submitted
- 19 Jul 2007
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Snyder S, Milbury K, Wagner R, Cohen L. Words matter: The use of generic "you" in expressive writing in an oncology setting. J Health Psychol. 2024 Jan;29(1):42-51. doi: 10.1177/13591053231182218. Epub 2023 Jun 26.
PubMed 37358056Milbury K, Spelman A, Wood C, Matin SF, Tannir N, Jonasch E, Pisters L, Wei Q, Cohen L. Randomized controlled trial of expressive writing for patients with renal cell carcinoma. J Clin Oncol. 2014 Mar 1;32(7):663-70. doi: 10.1200/JCO.2013.50.3532. Epub 2014 Jan 27.
PubMed 24470003
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Effects of Emotional Expression in Cancer
- ClinicalTrials.gov ID
- NCT00505310
- Acronym / sponsor ID
- ID00-168
- Conditions
- Kidney Cancer
- Keywords
- Kidney Cancer, Renal Cell Carcinoma, Emotional Expression, Writing, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Aug 2002 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 23 Jul 2007 (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 proposed study will assess the psychological and physiological benefits of an emotional expression intervention in patients with renal cancer. Patients will be randomly assigned to an emotional expression writing group or to a neutral writing group. This study will also evaluate the extent to which psychosocial factors mediate the intervention program and predict patients' recovery and adjustment to treatment. Potential mediators include level of cognitive processing, social networks/interactions, and sense of coherence and ability to find meaning in the illness experience.
Specific objectives of the proposed research are:
- To evaluate an emotional expression intervention in patients with renal cancer. Researchers will determine the extent to which an emotional expression writing-based intervention enhances adjustment during the first 12 months following diagnosis and treatment. Dimensions of adjustment will be assessed by examining indices of QOL, mental health, and stress (subjective symptoms of distress, perceived stress, and mood).
- To determine the effects of an emotional expression writing-based intervention on immune function. The immune measures assessed in this study will include both general and autologous tumor-specific immune responses including cytotoxicity to K562 target cells; cytotoxicity to autologous tumor target cells; and functional assessment of type-1 and type-2 cytokines using autologous tumor and polyclonal stimulants.
- To identify the psychosocial processes underlying the efficacy of the intervention.
Detailed description
Patients in this study will already be scheduled for surgery/ablation, or for chemotherapy and/or radiation treatment. Patients undergoing surgery/ablation will complete some questionnaires about their mood and quality of life. These questionnaires will happen about 6 weeks after their procedure, during their scheduled visit to M.D. Anderson to follow-up after their surgery. Patients scheduled to receive chemotherapy and/or radiation treatment will complete the same questionnaires around the time of their new patient consult visit at M.D. Anderson. They should take about 60 minutes to complete. About 8 teaspoons of blood will be drawn to measure immune function.
Patients will then be randomly picked (as in the toss of a coin) to be in one of two groups. One group will be the emotional expression writing group. The other group will be the neutral writing group.
Patients in both groups will be asked to write for 20 minutes on different topics at four different times. They will be asked to complete all assignments in their home. They will choose four separate times when they would like to do the writing assignments and a research assistant will prompt them with a phone call at those times. During these phone calls, patients will complete a brief mood evaluation before the start of the writing session. After 20 minutes, patients will receive another phone call to signal that they should stop writing. A second mood assessment will also be given at this time. Patients will be provided with a pre-addressed, stamped envelope for mailing each writing sample back to M. D. Anderson the day after it is completed.
Patients will complete some questionnaires about their mood and quality of life approximately 1 month, 4 months, and 10 months after their last writing assignment. They should take about 60 minutes to complete. About 8 teaspoons of blood will then be taken each time to measure immune function.
This is an investigational study. As many as 710 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Expression Writing | Experimental | Behavioral: Writing, Behavioral: Questionnaire20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment. |
| Neutral Writing | Experimental | Behavioral: Writing, Behavioral: Questionnaire20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Men or woman older than 18 years with stage I-IV renal cell carcinoma 2) Zubrod performance status of less than or equal to 2 3) have no serious intercurrent medical illness 4) read and speak English
Key exclusion criteria (1 listed)
- 1) Score of 23 or below on the Mini-mental 2) History of primary or secondary immunodeficiency 3) Taking immunosuppressive drugs such as systemic corticosteroid 4) Patients who are undergoing a surgical procedure and do not sign the general tissue consent form 5) Patients with major psychiatric diagnoses or currently seeking psychological counseling.
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 |
|---|---|---|
| Writing20 minutes of writing on different topics at four different times. | Behavioural | Emotional Expression Writing, Neutral Writing |
| QuestionnaireAlso: SurveyQuestionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment. | Behavioural | Emotional Expression Writing, Neutral Writing |
Primary outcome
To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer.
Time frame: 8 Years
1 secondary outcome
To learn how the expression of emotions affects quality of life, stress, and immune function.
Time frame: 8 Years
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 30 Aug 2022.
- Derived from this study: PubMed 37358056Snyder S, Milbury K, Wagner R, Cohen L. Words matter: The use of generic "you" in expressive writing in an oncology setting. J Health Psychol. 2024 Jan;29(1):42-51. doi: 10.1177/13591053231182218. Epub 2023 Jun 26.
- Derived from this study: PubMed 24470003Milbury K, Spelman A, Wood C, Matin SF, Tannir N, Jonasch E, Pisters L, Wei Q, Cohen L. Randomized controlled trial of expressive writing for patients with renal cell carcinoma. J Clin Oncol. 2014 Mar 1;32(7):663-70. doi: 10.1200/JCO.2013.50.3532. Epub 2014 Jan 27.
- University of Texas MD Anderson 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.
Lorenzo Cohen, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing and Questionnaire in people with Kidney Cancer, run by M.D. Anderson 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 1 inclusion and 1 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 30 Aug 2022. 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?
To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer. (time frame: 8 Years). 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 NCT00505310, which also lists 2 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 30 Aug 2022.