Biobehavioral Effects of Emotional Expression in Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Kidney Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/26/2018 |
| Start Date: | August 2002 |
| End Date: | August 2019 |
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.
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.
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.
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.
Inclusion Criteria:
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
Exclusion Criteria:
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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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